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OREGON HEALTH AUTHORITY,
PUBLIC HEALTH DIVISION

DIVISION 116

USE OF RADIONUCLIDES IN THE HEALING ARTS

333-116-0010

Purpose and Scope

This division contains the requirements and provisions for the production, preparation, compounding and use of radionuclides in the healing arts and for issuance of licenses authorizing the medical use of this material in Oregon. These requirements and provisions provide for the radiation safety of workers, the general public, patients, and human research subjects. The requirements and provisions of this division are in addition to, and not in substitution for, others in these rules. The requirements and provisions of these rules apply to applicants and licensees subject to this division unless specifically exempted.

(b) Is
identified as an authorized nuclear pharmacist on an Authority, Agreement State,
or U.S. Nuclear Regulatory Commission license that authorizes the use of radioactive
material in the practice of nuclear pharmacy;

(c) Is
identified as an authorized nuclear pharmacist on a license issued by an Authority,
Agreement State, or U.S. Nuclear Regulatory Commission specific licensee of broad
scope that is authorized to permit the use of radioactive material in the practice
of nuclear pharmacy; or

(d) Is
approved as an authorized nuclear pharmacist by a nuclear pharmacy licensed (authorized)
by the Authority, the U.S. Nuclear Regulatory Commission, or an Agreement State
to approve authorized nuclear pharmacists.

(b) Is
identified as an authorized user on an Authority, Agreement State, Licensing State
or U.S. Nuclear Regulatory Commission license that authorizes the medical use of
radioactive material; or

(c) Is
identified as an authorized user on a permit issued by an Authority, Agreement State,
or U.S. Nuclear Regulatory Commission licensee of broad scope that is authorized
to permit the medical use of radioactive material.

(7) "Black
Box" means the radiopharmaceutical production purification system used in a PET
facility.

(8) "Brachytherapy"
means a method of radiation therapy in which sources are used to deliver a radiation
dose at a distance of up to a few centimeters by surface, intracavitary, intraluminal,
or interstitial application.

(9) "Brachytherapy
source" means an individual sealed source or a manufacturer-assembled source train
or a combination of these sources that is designed to deliver a therapeutic dose
of radiation within a few centimeters, by surface, intracavitary, or interstitial
application that is not designed to be disassembled by the user.

(10) "Dedicated
check source" means a radioactive source that is used to assure the constant operation
of a radiation detection or measurement device over several months or years. This
source may also be used for other purposes.

(11) "Dental
use" means the intentional external administration of the radiation from radioactive
material to human beings in the practice of dentistry in accordance with a license
issued by a State or Territory of the United States, the District of Columbia, or
the Commonwealth of Puerto Rico.

(12) "Dentist"
means an individual licensed by a state or territory of the United States, the District
of Columbia, or the Commonwealth of Puerto Rico to practice dentistry.

(13) "Diagnostic
clinical procedures manual" means a collection of written procedures that describes
each method (and other instructions and precautions) by which the licensee performs
diagnostic clinical procedures; where each diagnostic clinical procedure has been
approved by the authorized user and includes the radiopharmaceutical, dosage, and
route of administration.

(14) "High
dose-rate remote afterloader" means a device that remotely delivers a brachytherapy
source, with a dose rate in excess of two gray (200 rad) per hour, to the point
or surface where the dose is prescribed.

(15) "Human
Research Subject" means a living person that an authorized user, conducting research,
obtains data resulting from the intentional internal or external administration
of radioactive material, or the radiation from radioactive material, to the individual.
For the purpose of these rules, unless otherwise noted, the term patient applies
to a human research subject.

(16) "Low
dose-rate remote afterloader" means a device that remotely delivers a brachytherapy
source, with a dose rate of less than two gray (200 rad) per hour, to the point
or surface where the dose is prescribed.

(18) "Manual
Brachytherapy", as used in this part, means a type of brachytherapy in which the
brachytherapy sources (e.g., seeds, ribbons) are manually placed on, or in close
proximity, to the treatment site or inserted directly into the tissue volume.

(19) "Medical
Event or Medical Error" means an event where a patient or human research subject:

(a) Receives
a dose that differs from the prescribed dose or dose that would have resulted from
the prescribed dosage by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5
Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to
the skin;

(b) Receives
a dose to the skin or an organ or tissue other than the treatment site that exceeds
by 0.5 Sv (50 rem) to an organ or tissue and 50 percent or more of the dose expected
from the administration defined in the written directive (excluding, for permanent
implants, seeds that were implanted in the correct site but migrated outside the
treatment site); or

(c) An
event resulting from intervention of a patient or human research subject in which
the administration of radioactive material or radiation from radioactive material
results or will result in unintended permanent functional damage to an organ or
a physiological system, as determined by a physician.

(20) "Medical
institution" means an organization in which more than one medical discipline is
practiced.

(21) "Medical
use" means the intentional internal or external administration of radioactive material,
or the radiation from radioactive material to patients or human research subjects
under the supervision of an authorized user.

(22) "Ministerial
change" means a change that is made, after ascertaining the applicable requirements,
by persons in authority in conformance with the requirements and without making
a discretionary judgment about whether those requirements should apply in the case
at hand.

(B) When
both the administered dosage differs from the prescribed dosage by more than 20
percent of the prescribed dosage and the difference between the administered dosage
and prescribed dosage exceed 1.11 megabecquerels (30 uCi).

(b) A
therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or I-131:

(A) Involving
the wrong individual, wrong radiopharmaceutical, or wrong route of administration;
or

(B) When
the administered dosage differs from the prescribed dosage by more than 20 percent
of the prescribed dosage.

(c) A
gamma stereotactic radiosurgery radiation dose:

(A) Involving
the wrong individual or wrong treatment site; or

(B) When
the calculated total administered dose differs from the total prescribed dose by
more than 10 percent of the total prescribed dose.

(B) When
the treatment consists of three or fewer fractions and the calculated total administered
dose differs from the total prescribed dose by more than 10 percent of the total
prescribed dose;

(C) When
the calculated weekly administered dose is 30 percent greater than the weekly prescribed
dose; or

(D) When
the calculated total administered dose differs from the total prescribed dose by
more than 20 percent of the total prescribed dose.

(e) A
brachytherapy radiation dose:

(A) Involving
the wrong individual, wrong radioisotope, or wrong treatment site (excluding, for
permanent implants, seeds that were implanted in the correct site but migrated outside
the treatment site);

(B) Involving
a sealed source that is leaking;

(C) When,
for a temporary implant, one or more sealed sources are not removed upon completion
of the procedure; or

(D) When
the calculated administered dose differs from the prescribed dose by more than 20
percent of the prescribed dose.

(f) A
diagnostic radiopharmaceutical dosage, other than quantities greater than 1.11 megabecquerels
(30 uCi) of either sodium iodide I-125 or I-131:

(A) Involving
the wrong individual, wrong radiopharmaceutical, wrong route of administration,
or when the administered dosage differs from the prescribed dosage; or

(25) "Nuclear
Pharmacist" means an authorized nuclear pharmacist, as defined in OAR 333-116-0020,
who has received additional training, pursuant to OAR 333-116-0910 and 333-116-0915
in the management and handling of radiopharmaceutical drugs and is authorized by
license to receive, use, transfer, and dispose of such radiopharmaceutical drugs.

(26) "Output"
means the exposure rate, dose rate or a quantity related in a known manner to these
rates from a teletherapy unit for a specified set of exposure conditions.

(27) "Patient
Intervention" means actions taken by a patient or human research subject, whether
intentional or unintentional, interrupt or terminate the administration of radioactive
materials or radiation.

(32) "Pharmacist"
means an individual licensed by a state or territory of the United States, The District
of Columbia, or the Commonwealth of Puerto Rico to practice pharmacy.

(33) "Physician"
means a medical doctor or doctor of osteopathy licensed by a state or territory
of the United States, the District of Columbia, or the Commonwealth of Puerto Rico
to prescribe drugs in the practice of medicine.

(34) "Podiatric
use" means the intentional external administration of the radiation from byproduct
material to human beings in the practice of podiatry in accordance with a license
issued by a state or territory of the United States, the District of Columbia, or
the Commonwealth of Puerto Rico.

(35) "Podiatrist"
means an individual licensed by a state or territory of the United States, the District
of Columbia, or the Commonwealth of Puerto Rico to practice podiatry.

(37) "Preceptor"
means an individual who provides, directs, or verifies training and experience required
for an individual to become an authorized user, an authorized medical physicist,
an authorized nuclear pharmacist, or a Radiation Safety Officer. The preceptor must
have previously met all of the applicable requirements and be so named on a radioactive
materials license issued by the Authority, the Nuclear Regulatory Commission, an
Agreement State or licensing state.

(38) "Prescribed
dosage" means the specified activity or range of activity of a radiopharmaceutical
or radioisotope as documented:

(a) In
a written directive; or

(b) Either
in the diagnostic clinical procedures manual or in any appropriate record in accordance
with the directions of the authorized user for diagnostic procedures.

(39) "Prescribed
dose" means:

(a) For
gamma stereotactic radiosurgery, the total dose as documented in the written directive;

(b) For
teletherapy, the total dose and dose per fraction as documented in the written directive;

(c) For
manual brachytherapy, either the total source strength and exposure time or the
total dose, as documented in the written directive; or

(d) For
remote brachytherapy afterloaders, the total dose and dose per fraction as documented
in the written directive.

(40) "Pulsed
dose-rate remote afterloader" means a special type of remote afterloading device
that uses a single source capable of delivering dose rates in the "high dose rate"
range, but is used to simulate the radiobiology of a low dose rate treatment by
inserting the source for a given fraction of each hour.

(41) "Radiation
Safety Officer" means an individual who:

(a) Meets
the requirements in OAR 333-116-0640, 333-116-0650, 333-116-0740 and 333-116-0760;
or

(b) Is
identified as a Radiation Safety Officer on:

(A) A
specific medical use license issued by the Nuclear Regulatory Commission or Agreement
State; or

(43) "Sealed
source" means any radioactive material that is encased in a capsule designed to
prevent leakage or escape of the radioactive material.

(44) "Stereotactic
Radiosurgery" means the use of external radiation in conjunction with a stereotactic
guidance device to very precisely deliver a dose to a tissue volume.

(45) "Structured
educational program" means an educational program designed to impart particular
knowledge and practical education through interrelated studies and supervised training.

(46) "Teletherapy"
means therapeutic irradiation in which the source of radiation is at a distance
from the body.

(47) "Teletherapy
physicist" means the individual identified as the qualified teletherapy physicist
on an Authority license.

(48) "Therapeutic
Dosage" means a dosage of unsealed byproduct material that is intended to deliver
a radiation dose to a patient or human research subject for palliative or curative
treatment.

(49) "Therapeutic
Dose" means a radiation dose delivered from a source containing byproduct material
to a patient or human research subject for palliative or curative treatment.

(50) "Treatment
site" means the anatomical description of the tissue intended to receive a radiation
dose, as described in a written directive.

(51) "Unit
dosage" means a dosage intended for medical use in a single patient or human research
subject that has been obtained from a manufacturer or preparer licensed by the Authority
as a nuclear pharmacy.

(52) "Visiting
authorized user" means an authorized user who is not identified on the license of
the licensee being visited.

(53) "Written
directive" means an order in writing for a specific patient, dated and signed by
an authorized user prior to the administration of a radiopharmaceutical or radiation,
except as specified in OAR 333-116-0125(1)(e), containing the following information:

(a) For
any administration of quantities greater than 1.11 megabecquerels (30 uCi) of either
sodium iodide I-125 or I-131: the dosage;

(b) For
a therapeutic administration of a radiopharmaceutical other than sodium iodide I-125
or I-131: the radiopharmaceutical, dosage, and route of administration;

(1) A licensee must implement the provisions in division 333-116 no later June 15, 2006.

(2) When a requirement in division 333-116 differs from the requirement in an existing license condition, the more restrictive requirement must govern until there is a license amendment or license renewal.

(3) Any existing license condition, not affected by a requirement in division 333-116, remains in effect until the license is amended or renewed.

(4) If a license condition exempted a licensee from a provision of division 333-116 on June 15, 2006, it will continue to exempt a licensee from the corresponding provision in division 333-116.

(5) If a license condition cites provisions in division 333-116 that will be deleted on June 15, 2006, then the license condition remains in effect until the license is amended or renewed to modify or remove the condition.

(6) Licensees must continue to comply with any license condition that requires it to implement procedures required by OAR 333-116-0525, 333-116-0580, 333-116-0583, and 333-116-0587 until there is a license amendment or renewal that modifies the license condition.

(1) No person shall manufacture, produce, acquire, receive, possess, use or transfer radioactive material for medical use except in accordance with a specific or general license issued pursuant to this division or as otherwise provided in this division.

(2) Unless prohibited by license condition, a specific license is not needed for an individual to:

(a) Receive, possess, use or transfer radioactive material in accordance with the rules in this division under the supervision of an authorized user as provided in OAR 333-116-0100; or

(b) Prepare unsealed byproduct material for medical use in accordance with the rules in this division under the supervision of an authorized nuclear pharmacist or authorized user as provided in OAR 333-116-0100.

(3) Notwithstanding the above requirements, any licensee licensed pursuant to this rule also is authorized to use radioactive material under the general license in OAR 333-102-0130 for the specified in vitro uses without filing the form as required by OAR 333-102-0130(2); the licensee is subject to the other provisions of 333-102-0130.

(2) An
application for a license for medical use of radioactive material as described in
OAR 333-116-0300, 333-116-0320, 333-116-0360, 333-116-0400, 333-116-0420 and 333-116-0480
and medical use of byproduct material as described in OAR 333-116-0485 must be made
by filing a "Radioactive Materials License Application: Medical." A request for
a license amendment or renewal may be submitted in letter format.

(3) Licensing
of remote afterloaders as described in OAR 333-116-0480 requires a separate "Radioactive
Materials License Application: The Medical License application must be completed
and submitted to the Authority. A request for a license amendment or renewal may
be submitted in letter format.

(4) An
application for a license for medical use of radioactive material as described in
OAR 333-116-0800, Licensing and Registration of Positron Emission Tomography (PET)
Facilities, must be made by filing a "Radioactive Materials License Application:
Medical."

(a) In
addition to the information required in the "Radioactive Materials License Application:
Medical," the application must also include information regarding any radiation
safety aspects of the medical use of the radioactive material that is not addressed
in this division, as well as any specific information necessary for:

(A) Radiation
safety precautions and instructions;

(B) Training
and experience of proposed users;

(C) Methodology
for measurement of dosages or doses to be administered to patients or human research
subjects; and

(1) Before
receiving or using radioactive material for a method or type of medical use not
permitted by the license issued under this division;

(2) Before
permitting anyone to work as an authorized user, authorized nuclear pharmacist,
or authorized medical physicist under the license except:

(a) For an
authorized user; an individual who meets the requirements in OAR 333-116-0760, 333-116-0660,
333-116-0670, 333-116-0680, 333-116-0683, 333-116-0687, 333-116-0690, 333-116-0710
and 333-116-0720.

(b) For an
authorized nuclear pharmacist; an individual who meets the requirements in OAR 333-116-0910
and 333-116-0760.

(c) For an
authorized medical physicist; an individual who meets the requirements in OAR 333-116-0905
and 333-116-0760.

(d) An individual
Identified as an authorized user, authorized nuclear pharmacist, or an authorized
medical physicist on a Nuclear Regulatory Commission or Agreement State license
that authorizes the use of radioactive material in medical use or in the practice
of nuclear pharmacy.

(3) Before
changing the Radiation Safety Officer except as provided in OAR 333-116-0090;

(4) Before
receiving radioactive material in excess of the amount authorized on the license;

(5) Before
adding to or changing the areas of use or mailing address identified on the license;
and

(6) Before
revising procedures required by OAR 333-116-0495, 333-116-0580, 333-116-0583, and
333-116-0587 as applicable where such revision reduces radiation safety.

(1) A licensee may conduct research
involving human research subjects only if it uses the byproduct materials specified
in, and for the uses authorized by its license.

(2) If the research is conducted,
funded, supported, or regulated by a federal agency that has implemented the Federal
Policy for the Protection of Human Subjects (Federal Policy), the licensee shall,
before conducting research:

(a) Obtain review and approval
of the research from an Institutional Review Board, as defined and described in
the Federal Policy; and

(b) Obtain "informed consent,"
as defined and described in the Federal Policy, from the human research subject.

(3) If the research is not
conducted, funded, supported, or regulated by another federal agency that has implemented
the Federal Policy, the licensee shall, before conducting research, submit a license
amendment request to the Authority and receive approval by amendment. The amendment
request must include a written commitment that the licensee must, before conducting
research;

(a) Obtain review and approval
of the research from an Institutional Review Board, as defined and described in
the Federal Policy; and

(b) Obtain informed consent,
as defined and described in the Federal Policy, from the human research subject.

(4) Nothing in this rule
relieves licensees from complying with other requirements in this division.

(1) A licensee must
provide to the Authority a copy of the board certification, the Nuclear Regulatory
Commission or Agreement State license, or the permit issued by a licensee of Broad
Scope for each individual no later than 30 days after the date that the licensee
permits the individual to work as an authorized user, or an authorized nuclear pharmacist
pursuant to OAR 333-116-0040(2)(a) through (d).

(2) A licensee
must notify the Authority by letter no later than 30 days after:

(a) An authorized
user, an authorized nuclear pharmacist, a Radiation Safety Officer or an authorized
medical physicist permanently discontinues performance of duties under the license
or has a name change;

(b) The licensee's
mailing address changes;

(c) The licensee's
name changes, but the name does not constitute a transfer of control of the license
as described in OAR 333-102-0305; or

(d) The licensee
has added to or changed the areas where radioactive material is used in accordance
with OAR 333-116-0200 and 333-116-0300.

(3) The licensee
must mail the documents required in this division to the Authority for review.

(1) The Authority must issue a license for the medical use of radioactive material if:

(a) The applicant has filed a "Radioactive Materials License Application: Medical" in accordance with the instructions in OAR 333-116-0035;

(b) The applicant has paid any applicable fee as provided in division 103 of these rules;

(c) The Authority finds the applicant equipped and committed to observe the safety standards established by the Authority in these rules for the protection of the public health and safety; and

(d) The applicant meets the requirements of division 102 of these rules.

(2) The Authority must issue a license for mobile services if the applicant:

(a) Meets the requirements in section (1) of this rule; and

(b) Assures that individuals or human research subjects to whom radiopharmaceuticals or radiation from implants will be administered may be released following treatment in accordance with OAR 333-116-0460.

The Authority may, upon application of any interested person or upon its own initiative, grant such exemptions from the regulations in this division as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.

(1) In addition
to the radiation protection program requirements of OAR 333-120-0020, a licensee's
management must approve in writing:

(a) Requests
for a license application, renewal, or amendment before submittal to the Authority;

(b) Any individual
before allowing that individual to work as an authorized user, authorized nuclear
pharmacist, or authorized medical physicist; and

(c) Radiation
protection program changes that do not require a license amendment and are permitted
under OAR 333-116-0123.

(2) A licensee's
management must appoint a Radiation Safety Officer, who agrees, in writing, to be
responsible for implementing the radiation protection program. The licensee, through
the Radiation Safety Officer, must ensure that radiation safety activities are being
performed in accordance with licensee-approved procedures and regulatory requirements.

(3) For up
to 60 days each year, a licensee may permit an authorized user or an individual
qualified to be a Radiation Safety Officer, under OAR 333-116-0650, 333-116-0740
and 333-116-0760, to function as a temporary Radiation Safety Officer and to perform
the functions of a Radiation Safety Officer, as provided in section (7) of this
rule, if the licensee takes the actions required in sections (2), (5), (7) and (8)
of this rule and notifies the Authority in accordance with OAR 333-116-0050(2).

(4) A licensee
may simultaneously appoint more than one temporary Radiation Safety Officer in accordance
with section (3) of this rule, if needed to ensure that the licensee has a temporary
Radiation Safety Officer that satisfies the requirements to be a Radiation Safety
Officer for each of the different types of uses of byproduct material permitted
by the license.

(5) A licensee
must establish the authority, duties, and responsibilities of the Radiation Safety
Officer in writing.

(7) Licensees
that are authorized for two or more different types of uses of radioactive material
under OAR chapter 333, division 116, must establish a Radiation Safety Committee
to oversee all uses of radioactive material permitted by the license. The Committee
must include an authorized user of each type of use permitted by the license, the
Radiation Safety Officer, a representative of the nursing service, and a representative
of management who is neither an authorized user nor a Radiation Safety Officer.
The Committee may include other members the licensee considers appropriate.

(8) A licensee's
Radiation Safety Committee must meet at intervals not to exceed six months. The
licensee must maintain minutes of each meeting in accordance with OAR 333-100-0057.

(9) A licensee
must retain a record of actions taken under sections (1), (2) and (5) of this rule
in accordance with OAR 333-100-0057. These records must be retained for the life
of the license.

(1) A licensee who permits the receipt, possession, use or transfer of radioactive material by an individual under the supervision of an authorized user as allowed by OAR 333-116-0030 must:

(a) In addition to the requirements in OAR 333-111-0010, instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, the licensee's written quality management program, the Oregon Rules for the Control of Radiation and the license conditions appropriate to that individual's use of radioactive material; and

(b) Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of radioactive material, written radiation protection procedures, written directive procedures, regulations of division 333-116, and license conditions with respect to the medical use of radioactive material.

(2) A licensee that permits the preparation of radioactive material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by OAR 333-116-0030(3) must:

(a) In addition to the requirements in OAR 333-111-0010, instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individual's use of radioactive material; and

(b) Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of radioactive material for medical use, the written radiation protection procedures established by the licensee and division 333-116, and license conditions.

(3) A licensee that permits supervised activities under sections (1) and (2) of this rule is responsible for the acts and omissions of the supervised individual.

(1) A written
directive must be prepared, dated and signed by an authorized user prior to administration
of I-131 sodium iodide greater than 1.11 Megabecquerels (MBq) (30 microcuries (uCi)),
or any therapeutic dosage of a radiopharmaceutical, or any therapeutic dose of radiation
from radioactive material.

(2) The
written directive must contain the patient or human research subject's name and
the following:

(a) For
any administration of quantities greater than 1.11 MBq (30 uCi) of sodium iodide
I-131 or I-125; the dosage;

(b) For
a therapeutic administration of a radiopharmaceutical other than sodium iodide I-131:
the radiopharmaceutical dosage, and route of administration;

(c) For
gamma stereotactic radiosurgery: target coordinates (including gamma angle), collimator
size, plug pattern, total dose for the treatment, and the total treatment volume
for each anatomically distinct treatment site;

(d) For
teletherapy: the total dose, dose per fraction, number of fractions, treatment site,
and overall treatment period;

(e) For
remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction,
number of fractions, and total dose; or

(f) For
all other brachytherapy:

(A) Prior
to implantation: treatment site, the radionuclide, number of sources and source
strengths or dose; and

(B) After
implantation but prior to completion of the procedure: the radionuclide, treatment
site, and total source strength and exposure time (or equivalently, the total dose).

(3) A
written revision to an existing written directive may be made if the revision is
dated and signed by an authorized user before the administration of the dosage of
unsealed byproduct material, the brachytherapy dose, the gamma stereotactic radiosurgery
dose, the teletherapy dose, or the next fractional dose.

(4) If,
because of the patient's condition, a delay in order to provide a written revision
to an existing written directive would jeopardize the patient's health, an oral
revision to an existing written directive is acceptable. The oral revision must
be documented as soon as possible in the patient's record. A revised written directive
must be signed by the authorized user within 48 hours of the oral revision.

(5) The
licensee must retain the written directive in accordance with OAR 333-100-0057.

(1) A licensee may permit any visiting authorized user to use licensed material for medical use under the terms of the licensee's license for 60 days each year if:

(a) The visiting authorized user has the prior written permission of the licensee's management and, if the use occurs on behalf of an institution, the institution's Radiation Safety Committee;

(b) The licensee has a copy of the Authority license or a license issued by the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State, that identifies the visiting authorized user by name as an authorized user for medical use; and

(c) Only those procedures for which the visiting authorized user is specifically authorized by the Authority license are performed by that individual.

(2) A licensee need not apply for a license amendment in order to permit a visiting authorized user to use licensed material as described in section (1) of this rule.

(3) A licensee must retain copies of the records specified in this rule in accordance with OAR 333-100-0057.

(1) The Authority will only license mobile nuclear medicine services in accordance with OAR 333-116-0300, 333-116-0320, and 333-116-0400 of this division and OAR 333-102-0130.

(2) Mobile nuclear medicine service licensees must:

(a) Obtain a letter signed by the management of each client for which services are rendered that authorizes use of licensed radioactive material at the client's address of use. This letter must clearly delineate the authority and responsibility of both the client and the mobile medical service. If the client is licensed, the letter must document procedures for notification, receipt, storage and documentation of transfer of radioactive material delivered to the client's address for use by the mobile medical service. The mobile nuclear medicine service licensee must retain the letter for three years after the last provision of service.

(b) Check instruments used to measure the activity of unsealed byproduct material for proper function before use at each client's address or on each day of use, whichever is more frequent. At a minimum, the check for proper function must include a constancy check;

(c) Check survey instruments for proper operation with a dedicated check source before use at each client's address; and

(d) Survey all areas of use to ensure compliance with the requirements in division 333-120 before leaving a client's address.

(3) If a mobile nuclear medicine service provides services that the client also is authorized to provide, the client is responsible for assuring that services are conducted in accordance with the rules in this division while the mobile nuclear medicine service is under the client's direction.

(4) A mobile nuclear medicine service may not order radioactive material to be delivered directly from the manufacturer or the distributor to the client's address of use unless the client has a radioactive materials license. Radioactive material delivered to the client's address of use must be received and handled in conformance with the client's license.

(5) A mobile medical service licensee must, at a minimum, maintain the following documents onboard each mobile unit:

(a) Current operating and emergency procedures;

(b) Copy of the current license;

(c) Copies of the letter required by section (2) of this rule;

(d) Current calibration records for each survey instrument and diagnostic equipment or dose delivery device in use; and

(6) A licensee must retain copies of the records specified in this rule in accordance with OAR 333-100-0057. The records required for subsections (2)(b), (2)(c) and (2)(d) of this rule must include the date of the survey or test, the results of the survey or test, the instrument used to make the survey or source used to perform the test, and the name of the individual who performed the survey or test.

(1) A licensee may revise its radiation protection program without Authority approval if:

(a) The revision does not require a license amendment under OAR 333-116-0040;

(b) The revision is in compliance with the regulations and the license;

(c) The revision has been reviewed and approved by the Radiation Safety Officer, licensee management and, if applicable, the Radiation Safety Committee; and

(d) The affected individuals are instructed on the revised program before the changes are implemented.

(2) A licensee must retain a record of each change in accordance with OAR 333-100-0057. The record must include the effective date of the change, a copy of the old and new radiation safety procedures, the reason for the change, a summary of radiation safety matters that were considered before making the change, the signature of the Radiation Safety Officer, and the signatures of the affected authorized users and of management, or, in a medical institution, the Radiation Safety Committee's chairman and the management representative.

(1) Each applicant or licensee under this division, as applicable, must establish and maintain a written quality management program to provide high confidence that radioactive material or radiation from radioactive material will be administered as directed by the authorized user. The quality management program must include written policies and procedures to meet the following specific objectives:

(D) Any administration of quantities greater than 1.11 megabecquerels (30 uCi) of either sodium iodide I-125 or I-131; or

(E) Any therapeutic administration of a radiopharmaceutical, other than sodium iodide I-125 or I-131;

(b) That, prior to each administration, the patient's identity is verified by more than one method as the individual named in the written directive;

(c) That final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in accordance with the respective written directives;

(d) That each administration is in accordance with the written directive; and

(e) That any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.

NOTE: If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented immediately in the patient's record and a revised written directive is signed by the authorized user within 48 hours of the oral revision. Also, a written revision to an existing written directive may be made for any diagnostic or therapeutic procedure provided that the revision is dated and signed by an authorized user prior to the administration of the radiopharmaceutical dosage, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next teletherapy fractional dose. If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive will be acceptable, provided that the information contained in the oral directive is documented immediately in the patient's record and a written directive is prepared within 24 hours of the oral directive.

(2) The licensee shall:

(a) Develop procedures for and conduct a review of the quality management program including, since the last review, an evaluation of:

(A) A representative sample of patient administrations,

(B) All recordable events, and

(C) All misadministrations to verify compliance with all aspects of the quality management program; these reviews shall be conducted at intervals no greater than 12 months;

(b) Evaluate each of these reviews to determine the effectiveness of the quality management program and, if required, make modifications to meet the objectives of subsection (2)(a) of this rule; and

(c) Retain records of each review, including the evaluations and findings of the review, in an auditable form for three years.

(3) The licensee shall evaluate and respond, within 30 days after discovery of the recordable event, to each recordable event by:

(a) Assembling the relevant facts including the cause;

(b) Identifying what, if any, corrective action is required to prevent recurrence; and

(c) Retaining a record, in an auditable form, for five years or until inspected by the Authority, of the relevant facts and what corrective action, if any, was taken.

(4) The licensee shall retain:

(a) Each written directive; and

(b) A record of each administered radiation dose or radiopharmaceutical dosage where a written directive is required in subsection (1)(a) of this rule, in an auditable form, for five years, or until inspected by the Authority, after the date of administration.

(5) The licensee may make modifications to the quality management program to increase the program's efficiency provided the program's effectiveness is not decreased. The licensee shall furnish the modification to the Authority within 30 days after the modification has been made.

(6) Each applicant for a new license, as applicable, shall submit to the Authority in accordance with OAR 333-102-0190 a quality management program as part of the application for a license and implement the program upon issuance of the license by the Authority.

((1) For a misadministration that meets
the definition in OAR 333-116-0020 a licensee must:

(a) Notify the Authority
by telephone no later than the next calendar day after discovery of the misadministration
and provide information as outlined in paragraphs (b)(A) through (b)(H) of this
section.

NOTE: The 24-hour phone number of the
Authority is (971) 673-0490.

(b) Submit a written report to the Authority
within 15 days after the discovery of the misadministration. The written report
must include:

(A) The licensee's name;

(B) The prescribing physician's
name;

(C) A brief description of
the event to include:

(i) Prescribed dose; and

(ii) Delivered dose.

(D) Why the event occurred;

(E) The effect on the patient;

(F) What improvements are
needed to prevent recurrence;

(G) Actions taken to prevent
recurrence; and

(H) Certification that the
licensee notified the patient, or the patient's responsible relative or guardian
(this person will be subsequently referred to as "the patient" in this section),
and if not, why not, and if the patient was notified, what information was provided
to the patient. The report must not include the patient's name or other information
that could lead to identification of the patient.

(c) The licensee must notify
the referring physician of the affected patient and the patient or a responsible
relative or guardian, unless the referring physician agrees to inform the patient
or believes, based on medical judgment, that telling the patient or the patient's
responsible relative or guardian would be harmful to one or the other, respectively.
These notifications must be made within 24 hours after the licensee discovers the
misadministration. If the referring physician, patient or the patient's responsible
relative or guardian cannot be reached within 24 hours, the licensee must notify
them as soon as practicable. The licensee is not required to notify the patient
or the patient's responsible relative or guardian without first consulting the referring
physician; however, the licensee must not delay medical care for the patient because
of this.

(d) If the patient was notified,
the licensee also must furnish, within 15 days after discovery of the misadministration,
a written report to the patient by sending either:

(A) A copy of the report
that was submitted to the Authority; or

(B) A brief description of
both the event and the consequences as they may affect the patient, provided a statement
is included that the report submitted to the Authority can be obtained from the
licensee.

(2) Each licensee must retain
a record of each misadministration in accordance with OAR 333-100-0057. The record
must contain the names of all individuals involved in the event (including the physician,
allied health personnel, the patient, and the patient's referring physician), the
patient's social security number or identification number if one has been assigned,
a brief description of the misadministration, why it occurred, the effect on the
patient, what improvements are needed to prevent recurrence, and the actions taken
to prevent recurrence.

(3) Aside from the notification
requirement, nothing in this rule must affect any rights or duties of licensees
and physicians in relation to each other, patients or responsible relatives or guardians.

(1) Radioactive material manufactured, produced, labeled, prepared, compounded, packaged and distributed in accordance with a license issued pursuant to these rules or the equivalent rules of another Agreement State, a Licensing State or the U.S. Nuclear Regulatory Commission.

(2) Reagent kits, radiopharmaceuticals, and/or radiobiologics that have been manufactured, labeled, packaged and distributed in accordance with an approval issued by the U.S. Department of Health and Human Services, Food and Drug Administration.

(3) Radiopharmaceuticals compounded from a prescription in accordance with the regulations of the state Board of Pharmacy.

(4) Teletherapy and brachytherapy sources manufactured and distributed in accordance with a license issued pursuant to these regulations, or the equivalent regulations of another Agreement State, a Licensing State, or the Nuclear Regulatory Commission.

(5) Sealed sources or devices non-commercially transferred from a 10 CFR, Part 35 licensee or Agreement State medical licensee.

(1) Each licensee must establish written quality control procedures for all diagnostic equipment used to obtain images from radionuclide studies. As a minimum the quality control procedures and frequencies must include quality control procedures recommended by equipment manufacturers or procedures which have been approved by the Authority. The licensee must conduct quality control procedures in accordance with written procedures.

(2) Copies of procedures and records generated from implementing these procedures must be maintained in accordance with OAR 333-100-0057.

(1) A medical use licensee authorized to administer either radiopharmaceuticals or unsealed radioactive materials must possess a dose calibrator and use it to measure the amount of activity of radionuclides prior to administration to each patient or human research subject. The licensee must also develop, implement and maintain written procedures for proper calibration and operation of the dose calibrator.

(2) At a minimum, a licensee must:

(a) Check each dose calibrator for constancy and proper operation with a dedicated check source at the beginning of each day of use. To satisfy the requirement of this rule, the check must be done on a frequently used setting with a sealed source of not less than 1.85 megabecquerels (50 uCi) of any photon-emitting radionuclide with a half-life greater than 90 days. The results of this test must be within +ten percent of the sources stated activity. Sources used for the daily constancy test must be determined by the manufacturer to be within +five percent of the stated activity and traceable to the National Institute of Standards and Technology or other standards recognized as being equivalent by the National Institute of Standards and Technology.

(b) Test each dose calibrator for accuracy upon installation and at intervals not to exceed 12 months thereafter by assaying at least two sealed sources containing different photon-emitting radionuclides 1.85 megabecquerels (50 uCi) each, at least one of which has a principal photon energy between 100 keV and 500 keV. All sources used to satisfy the accuracy test must be determined by the manufacturer to be within +five percent of the stated activity and traceable to the National Institute of Standards and Technology or other standards recognized as being equivalent by the National Institute of Standards and Technology;

(c) Test each dose calibrator for linearity upon installation and at intervals not to exceed three months thereafter over the range of use between 1.1 megabecquerels (30 microcuries) and the highest dosage that will be administered; and

(d) Test each dose calibrator for geometry dependence upon installation over the range of volumes and volume configurations for which it will be used. The licensee must keep a record of this test for the duration of the use of the dose calibrator.

(3) A licensee must mathematically correct dosage readings for any geometry or linearity error that exceeds 10 percent if the dosage is greater than 1.1 megabecquerels (30 microcuries) and must repair or replace the dose calibrator if the accuracy or constancy error exceeds 10 percent.

(4) A licensee must also perform checks and tests required by section (2) of this rule following adjustment or repair of the dose calibrator and prior to use.

(5) A licensee must retain a record of each check and test required by section (2) of this rule in accordance with OAR 333-100-0057. The records required by section (2) of this rule must include:

(a) For constancy, the model and serial number of the dose calibrator, the identity and calibrated activity of the radionuclide contained in the check source, the date of the check, the activity measured, the instrument settings and the initials of the individual who performed the check;

(b) For accuracy, the model and serial number of the dose calibrator, the model and serial number of each source used and the identity of the radionuclide contained in the source and its activity, the date of the test, the results of the test, the instrument settings and the signature of the Radiation Safety Officer;

(c) For linearity, the model and serial number of the dose calibrator, the calculated activities, the measured activities, the date of the test and the signature of the Radiation Safety Officer; and

(d) For geometry dependence, the model and serial number of the dose calibrator, the configuration and calibrated activity of the source measured, the activity of the source, the activity measured and the instrument setting for each volume measured, the date of the test and the signature of the Radiation Safety Officer.

Possession, Use Calibration, and Check of Instruments to Measure Dosages of Alpha- or Beta-emitting Radionuclides

(1) For other than unit dosages, a licensee must possess and use instrumentation to measure the radioactivity of alpha- or beta-emitting radionuclides. A licensee must measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha- or beta-emitting radionuclides prior to administration to each patient or human research subject.

(2) A licensee must develop, implement, and maintain written procedures for use of the instrumentation. At a minimum, a licensee must:

(a) Perform tests before initial use, and following repair, on each instrument for accuracy, linearity, and geometry dependence, unless it is not appropriate for the use of the instrument; and make adjustments when necessary;

(b) Perform accuracy annually;

(c) Perform linearity tests annually over the range of medical use; and

(d) Check each instrument for constancy and proper operation at the beginning of each day of use.

(3) Accuracy tests must be performed with source(s) that are traceable to National Institute of Standards and Technology (NIST) or by a supplier who has compared the source to a source that was calibrated by NIST.

(4) A licensee must retain a record of each check and test required by this rule in accordance with OAR 333-100-0057.

(1) A licensee must ensure that the survey instruments used to show compliance with OAR chapter 333, divisions 116 and 120 have been calibrated before first use, annually and following repair.

(2) To satisfy the requirements of section (1) of this rule the licensee must:

(a) Calibrate all required scale readings up to 10 millisieverts (1000 mrem) per hour with a radiation source;

(b) For each scale that must be calibrated, calibrate two readings separated by at least 50 percent of scale reading; and

(c) Conspicuously note on the instrument the date of calibration.

(3) To satisfy the requirements of section (2) of this rule, the licensee must:

(a) Consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 10 percent; and

(b) Consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 20 percent if a correction chart or graph is conspicuously attached to the instrument.

(4) A licensee must check each survey instrument for proper operation with the dedicated check source before each use. (5) The licensee must retain a record of each calibration required in section (1) of this rule in accordance with OAR 333-100-0057. The record must include:

(a) A description of the calibration procedure; and

(b) A description of the source used and the certified exposure rates from the source and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, the signature of the individual who performed the calibration and the date of calibration.

(6) To meet the requirements of sections (1), (2) and (3) of this rule, the licensee may obtain the services of individuals licensed by the Authority, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State to perform calibrations of survey instruments. Records of calibrations which contain information required by section (5) of this rule must be maintained by the licensee calibration in accordance with OAR 333-100-0057.

Determination of Dosages of Unsealed Radioactive Material for Medical Use

A licensee must:

(1) Assay, within 30 minutes before medical use, the activity of each radiopharmaceutical dosage that contains more than 370 kilobecquerels (10 uCi) of an alpha-, beta-, or photon-emitting radionuclide;

(2) For a dosage of an alpha- or beta-emitting radionuclide prepared by the licensee, this determination must be made by direct measurement or by a combination of measurements and calculations.

(3) A licensee must not use a dosage if the dosage differs from the prescribed dosage by more than 20 percent, unless authorized in writing by an authorized user.

(4) Retain a record of the assays required by this rule in accordance with OAR 333-100-0057. The record must contain the:

(a) Generic name, trade name or abbreviation of the radiopharmaceutical, its lot number and expiration dates and the radionuclide;

(b) Patient's name and identification number if one has been assigned;

(c) Prescribed dosage and activity of the dosage at the time of assay or a notation that the total activity is less than 370 kilobecquerels (10 uCi);

Any person authorized by OAR 333-116-0030
for medical use of radioactive material may receive, possess and use the following
radioactive material for check, calibration and reference use:

(1) Sealed sources manufactured
and distributed by persons specifically licensed pursuant to OAR 333-102-0290 or
equivalent provisions of the U.S. Nuclear Regulatory Commission (NRC) Agreement
State or Licensing State and that do not exceed 1.11GBq (30 mCi) each;

(2) Any radioactive material
listed in OAR 333-116-0300, 333-116-0320 or 333-116-0360 with a half-life of 100
days or less in individual amounts not to exceed 1.11GBq (30 mCi), except Y-90 sources
not to exceed 2.8 GBq (75 mCi);

(3) Any radioactive material
listed in OAR 333-116-0300, 333-116-0320 or 333-116-0360 with a half-life greater
than 100 days in individual amounts not to exceed 7.4 MBq (200 uCi) each; and

Requirements for Possession of Sealed Sources and Brachytherapy Sources

(1) A licensee in possession of any sealed source or brachytherapy source must follow the radiation safety and handling instructions supplied by the manufacturer or equivalent instructions approved by the Authority, and must maintain the instructions for the duration of source use in a legible form convenient to users.

(2) A licensee in possession of a sealed source must assure that:

(a) The source is tested for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within six months before transfer to the licensee; and

(b) The source is tested for leakage at intervals not to exceed six months or at intervals approved by the Authority, another Agreement State, a Licensing State or the U.S. Nuclear Regulatory Commission in the Sealed Source and Device Registry (SS&D).

(3) To satisfy the leak test requirements of this division, the licensee must assure that:

(a) Leak tests are capable of detecting the presence of 185 Bq (0.005 uCi) of radioactive material on the test sample, or in the case of radium, the escape of radon at the rate of 37 Bq (0.001 uCi) per 24 hours;

(b) Test samples are taken from the source or from the surfaces of the device in which the source is mounted or stored on which radioactive contamination might be expected to accumulate; and

(c) For teletherapy units, test samples are taken when the source is in the "off" position.

(4) A licensee must retain leak test records in accordance with OAR 333-100-0057. The records must contain the model number and serial number if assigned, of each source tested, the identity of each source radionuclide and its estimated activity, the measured activity of each test sample expressed in microcuries (Bq), a description of the method used to measure each test sample, the date of the test and the signature of the Radiation Safety Officer.

(5) If the leak test reveals the presence of 185 Bq (0.005 uCi) or more of removable contamination, the licensee must:

(a) Immediately withdraw the sealed source from use and store it in accordance with the requirements of these rules; and

(b) File a report within five days of receiving the leakage test results with the Authority describing the equipment involved, the test results and the action taken.

(6) A licensee need not perform a leak test on the following sources:

(a) Sources containing only radioactive material with a half-life of less than 30 days;

(b) Sources containing only radioactive material as a gas;

(c) Sources containing 3.7 MBq (100 uCi) or less of beta or photon-emitting material or 370 kBq (10 uCi) or less of alpha-emitting material;

(d) Seeds of iridium-192 encased in nylon ribbon; and

(e) Sources stored and not being used. The licensee must, however, test each such source for leakage before any use or transfer unless it has been tested for leakage within six months before the date of use or transfer.

(7) A licensee in possession of a sealed source or brachytherapy source must conduct a semi-annual physical inventory of all such sources in its possession. The licensee must retain each inventory record in accordance with OAR 333-100-0057. The inventory records must contain the model number of each source and serial number if one has been assigned, the identity of each source radionuclide and its estimated activity, the location of each source, date of the inventory and the signature of the Radiation Safety Officer.

Each syringe
and vial that contains unsealed byproduct material must be labeled to identify the
radiopharmaceutical drug. Each syringe shield and vial shield must also be labeled
unless the label on the syringe or vial is visible when shielded. The label must
include the radiopharmaceutical name or abbreviation, the type of diagnostic study
or therapy procedure to be performed and the patient's name.

(1) A licensee
must survey with an appropriate radiation detection survey instrument, at the end
of each day of use, all areas where radiopharmaceuticals are routinely prepared
for use or administered. Radiation surveys are not required in areas where patients
or human research subjects are confined when they cannot be released under OAR 333-116-0260.
Radiation surveys are required when patients receive a therapeutic dose or brachytherapy
implant and prior to release.

(2) A
licensee must survey with an appropriate radiation detection survey instrument at
least once each week all areas where radiopharmaceuticals or radioactive wastes
are stored.

(3) A
licensee must conduct the surveys required by section (1) and (2) of this rule so
as to be able to measure dose rates as low as 1 uSv (0.1 mrem) per hour.

(4) A
licensee must establish dose rate action levels for the surveys required by sections
(1) and (2) of this rule and must require that the individual performing the survey
immediately notify the Radiation Safety Officer if a dose rate exceeds an action
level.

(5) A
licensee must survey for removable contamination each day of use all areas where
radiopharmaceuticals are routinely prepared for use or administered and each week
where radioactive materials are stored.

(6) A
licensee must conduct the surveys required by section (5) of this rule so as to
be able to detect contamination on each wipe sample of 33.3 Bq (2000 dpm).

(7) A
licensee must establish removable contamination action levels for the surveys required
by section (5) of this rule and must require that the individual performing the
survey immediately notify the Radiation Safety Officer if contamination exceeds
action levels.

(8) A
licensee must retain a record of each survey required by this rule in accordance
with OAR 333-100-0057. The record must include the date of the survey, a sketch
of each area surveyed, action levels established for each area, the measured dose
rate at several points in each area expressed in Sv mrem per hour or the removable
contamination in each area expressed in Bq (dpm) per 100 square centimeters, the
serial number and the model number of the instrument used to make the survey or
analyze the samples and the initials of the individual who performed the survey.

Surveys Of Patients And Human Research Subjects Treated With A Remote Afterloader Unit

(1) Before releasing a patient or a human research subject from licensee control, a licensee shall survey the patient or the human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm that the source(s) has been removed from the patient or human research subject and returned to the safe shielded position.

(2) A licensee shall retain a record of these surveys in accordance with OAR 333-100-0057.

(1) The licensee
may authorize the release from its control of any individual who has been administered
unsealed byproduct material or implants containing byproduct material if the total
effective dose equivalent to any other individual from exposure to the released
individual is not likely to exceed five millisieverts (0.5 rem).

(2) The licensee
must provide the released individual, or the individual's parent or guardian, with
instructions, including written instructions, on actions recommended to maintain
radiation exposures to other individuals as low as is reasonably achievable if the
total effective dose equivalent to any other individual is likely to exceed one
millisievert (0.1 rem). If the dose to a breast-feeding infant or child could exceed
one millisievert (0.1 rem) assuming there were no interruption of breast-feeding,
the instructions must also include:

(a) Guidance
on the interruption or discontinuation of breast-feeding; and

(b) Information
on the potential consequences, if any, of failure to follow the guidance.

(3) The
licensee must maintain a record of the basis for authorizing the release of an individual,
for a minimum of five years after the date of release in accordance with OAR 333-100-0057.

(4) The
licensee must maintain a record, for a minimum of five years after the date of release,
in accordance with OAR 333-100-0057, that instructions were provided to a breast-feeding
woman if the radiation dose to the infant or child from continued breast-feeding
could result in a total effective dose equivalent exceeding five millisieverts (0.5
rem).

(1) A licensee
may hold radioactive material with a physical half-life of less than 120 days for
decay-in-storage before disposal in ordinary trash and is exempt from the requirements
of OAR 333-120-0500 of these rules if the licensee:

(a) Holds
radioactive material for decay a minimum of 10 half-lives;

(b) Monitors
radioactive material at the container surface before disposal as ordinary trash
and determines that its radioactivity cannot be distinguished from the background
radiation level with an appropriate radiation detection survey instrument for the
radiation being monitored, set on its most sensitive scale and with no interposed
shielding;

(c) Removes
or obliterates all radiation labels, except radiation labels on materials that are
within containers and that will be managed as biomedical waste after they have been
released from the licensee; and

(d) Separates
and monitors each generator column individually with all radiation shielding removed
to ensure that its contents have decayed to background radiation level before disposal.

(2) For
radioactive material disposed in accordance with these rules the licensee must retain
a record of each disposal until inspection by the Authority. The record must include
the date of the disposal, the date on which the radioactive material was placed
in storage, the model and serial number of the survey instrument used, the background
dose rate, the radiation dose rate measured at the surface of each waste container
and the name of the individual who performed the survey.

(3) Iodine-125
waste in microcurie amounts may be held for a minimum of five half-lives. Such waste
must be surveyed with an appropriate instrument prior to disposal to confirm that
waste is indistinguishable from background.

Use of Unsealed Radioactive Material for Uptake, Dilution or Excretion Studies for Which a Written Directive Is Not Required

(1) A licensee may use any unsealed radioactive material for a diagnostic use involving measurements of uptake, dilution or excretion that:

(a) The Food and Drug Administration (FDA) has accepted a "Notice of Claimed Investigational Exemption for a New Drug" (IND) or approved a "New Drug Application" (NDA); and

(b) Is obtained from a manufacturer or preparer licensed under OAR 333-102-0285 or equivalent Nuclear Regulatory Commission or Agreement State requirements; or

(c) Is prepared and compounded by an authorized nuclear pharmacist, a physician who is an authorized user, or an individual under the supervision of either as specified in OAR 333-116-0100, 333-116-0670 and 333-116-0670(3)(B); or

(d) Is prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA.

(2) A licensee using a radiopharmaceutical specified in section (1) of this rule for a clinical procedure other than one specified in the product label or package insert instructions for use must comply with the product label or package insert instructions regarding physical form, route of administration and dosage range.

A licensee authorized to use radioactive material for uptake, dilution and excretion studies must have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range one Sv (0.1 mrem) per hour to one mSv (100 mrem) per hour. The instrument must be operable and calibrated in accordance with OAR 333-116-0170.

Use of Radiopharmaceuticals, Generators and Reagents Kits for Imaging and Localization Studies for Which a Written Directive Is Not Required

(1) A licensee
may use any radioactive material in a diagnostic radiopharmaceutical, except aerosol
or gaseous form, or any generator or reagent kit for preparation and diagnostic
use of a radiopharmaceutical containing radioactive material for:

(a) Which
the Food and Drug Administration has accepted a "Notice of Claimed Investigational
Exemption for a New Drug" (IND) or approved a "New Drug Application" (NDA); or

(b) Which
is prepared and compounded by an authorized nuclear pharmacist, a physician who
is an authorized user, or an individual under the supervision of either as specified
in OAR 333-116-0100, 333-116-0670 or 333-116-0680; or

(c) Obtained
from a manufacturer or preparer licensed under divisions 333-102 and 333-116 or
equivalent Nuclear Regulatory Commission or Agreement State requirements.

(2) A
licensee using radiopharmaceuticals specified in section (1) of this rule for clinical
procedures other than one specified in the product label or package insert instructions
must comply with the product label or package insert regarding physical form and
dosage range.

(3) A
licensee must elute generators in compliance with OAR 333-116-0330 and prepare radiopharmaceuticals
from kits in accordance with the manufacturer's instructions.

(4) Technetium-99m
pentetate as an aerosol for lung function studies is not subject to the restrictions
in section (1) of this rule. Provided the conditions of OAR 333-116-0340 are met,
a licensee must use radioactive aerosols or gases only if specific application is
made to and approved by the Authority.

(1) A licensee
must not administer to humans a radiopharmaceutical containing more than 0.15 kBq
(0.15 uCi) of molybdenum-99 per MBq (mCi) of technetium-99m; or

(2) More
than 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride
injection (0.02 microcurie of strontium-82 per millicurie of rubidium-82 chloride);
or more than 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82
chloride injection (0.2 microcurie of strontium-85 per millicurie of rubidium-82).

(3) A
licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m
generators must measure the molybdenum-99 concentration of the first eluate after
receipt of a generator to demonstrate compliance with section (1) of this rule.

(4) A
licensee that uses a strontium-82/rubidium-82 generator for preparing a rubidium-82
radiopharmaceutical shall, before the first patient use of the day, measure the
concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance
with section (1) of this rule.

(5) A
licensee who must measure molybdenum concentration or strontium-82 and strontium-85
must retain a record of each measurement in accordance with OAR 333-100-0057. The
record must include, for each elution or extraction of technetium-99m, the measured
activity of the technetium expressed in MBq (mCi), the measured activity of the
molybdenum expressed in kBq (uCi), the ratio of the measures expressed as kBq (uCi)
of molybdenum per MBq (mCi) of technetium, the date of the test and the initials
of the individual who performed the test.

(6) A
licensee must report immediately to the Authority each occurrence of molybdenum-99
concentration exceeding the limits specified in section (1) of this rule.

(1) A licensee who administers radioactive aerosols or gases must do so with a system that will keep airborne concentrations within the limits prescribed by OAR 333-120-0130 and 333-120-0180.

(2) The system must either be directly vented to the atmosphere through an air exhaust or provide for collection and decay or disposal of the aerosol or gas in a shielded container.

(3) A licensee must only administer radioactive gases in rooms that are at negative pressure compared to surrounding rooms.

(4) Before receiving, using or storing a radioactive gas, the licensee must calculate the amount of time needed after a release to reduce the concentration in the area of use to the occupational limit listed in 10 CFR Part 20 Appendix B to 20.1001 to 20.2401. The calculation must be based on the highest activity of gas handled in a single container and the measured available air exhaust rate.

(5) A licensee must post the time calculated in accordance with section (4) of this rule at the area of use and require that, in case of a gas spill, individuals evacuate the room until the posted time has elapsed.

(6) A licensee must check the operation of collection systems before each use and measure the ventilation rates in areas of use at intervals not to exceed six months. Records of these checks and measurements must be maintained for five years or until inspected by the Authority.

(7) A copy of the calculations required in section (4) of this rule must be recorded and retained for the duration of the license.

[Publications: Publications referenced are available from the agency.]

A licensee authorized to use radioactive material for imaging and localization studies must have in its possession a portable, radiation detection survey instrument capable of detecting dose rates over the range of one Sv (0.1 mrem) per hour to one mSv (100 mrem) per hour and a portable radiation measurement survey instrument capable of measuring dose rates over the range ten Sv (1 mrem) per hour to ten millisieverts (1000 mrem) per hour. The instruments must be operable and calibrated in accordance with OAR 333-116-0170.

Use of Unsealed Radioactive Materials or Radiopharmaceuticals for Which a Written Directive is Required

A licensee may
use for therapeutic administration any unsealed radioactive material or radiopharmaceutical
prepared for medical use that:

(1) Has
been granted acceptance or approval by the Food and Drug Administration; and

(2) Has
been prepared by an authorized nuclear pharmacist, a physician who is an authorized
user on a license from the Authority, other Agreement State, or the U.S. Nuclear
Regulatory Commission and meets the specified requirements in OAR 333-116-0670 or
333-116-0680; or

(3) Has
been manufactured and distributed under a license from the Authority, other Agreement
State, or the U.S. Nuclear Regulatory Commission; or

(4) Obtained
from and prepared by the Authority or Nuclear Regulatory Commission or Agreement
State licensee for use in research in accordance with an Investigational New Drug
(IND) protocol accepted by FDA; or

(5) Prepared
by the licensee for use in research in accordance with an Investigational New Drug
(IND) protocol accepted by FDA.

(1) A licensee must provide oral and written radiation safety instruction for all personnel caring for patients or human research subjects undergoing radiopharmaceutical therapy who cannot be released under OAR 333-116-0260. Refresher training must be provided at intervals not to exceed one year.

(2) To satisfy section (1) of this rule, the instruction must describe the licensee's procedures for:

(a) Patient or human research subject control;

(b) Visitor control; including

(A) Routine visitation to hospitalized individuals in accordance with OAR 333-120-0180(1)(a); and

(B) Visitation authorized in accordance with OAR 333-120-0180(3).

(c) Contamination control;

(d) Waste control; and

(e) Notification of the Radiation Safety Officer or authorized user in case of the patient's death or medical emergency.

(3) A licensee must maintain, in accordance with OAR 333-100-0057, a list of individuals receiving instruction required by section (1) of this rule, a description of the instruction, the date of instruction and the name of the individual who gave the instruction.

(1) For each patient or human research subject receiving radiopharmaceutical therapy and hospitalized for compliance with OAR 333-116-0260 or 333-116-0190, a licensee must:

(a) Provide a private room with a private sanitary facility;

(b) Post the door with a "Caution: Radioactive Material" sign and note on the door or on the patient's chart where and how long visitors may stay in the patient's room;

(c) Authorize visits by individuals under age 18 only on a case-by-case basis with the approval of the authorized user after consultation with the Radiation Safety Officer;

(d) Promptly after administration of the dosage, measure the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with the requirements of OAR 333-120-0180 of these rules and retain until inspection by the Authority a record of each survey that includes the time and date of the survey, a plan of the area or list of points surveyed, the measured dose rate at several points expressed in mrem per hour, the instrument used to make the survey and the initials of the individual who made the survey;

(e) Either monitor material and items removed from the room to determine that any contamination cannot be distinguished from the natural background radiation level with an appropriate radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle materials and items as radioactive waste;

(f) Instruct the patient or human research subject and, where appropriate, the individual's family, orally and in writing concerning radiation safety precautions that will help to keep radiation dose to household members and the public as low as reasonably achievable before authorizing release of the individual;

(g) Survey the room and private sanitary facility for removable contamination with an appropriate radiation detection survey instrument before assigning another patient to the room. The room must not be reassigned until removable contamination is less than 33.3 Bq (2000 dpm) per 100 square centimeters; and

(h) Measure the thyroid burden of each individual who helped prepare or administer a liquid dosage of iodine-131 within three days after administering the dosage. A record of each thyroid burden measurement must be retained in accordance with OAR 333-120-0650 of these rules. Each record must contain the date of measurement, the name of the individual whose thyroid burden was measured, the calculated thyroid burden, the effective dose equivalent, the name of the individual who made the measurements and the signature of the Radiation Safety Officer. Other procedures acceptable to the Authority may be used for individuals who only prepare, but do not administer, doses of stabilized I-131.

(2) A licensee must notify the Radiation Safety Officer or the authorized user immediately if the patient or human research subject dies or has a medical emergency.

A licensee authorized
to use radioactive material for radiopharmaceutical therapy must have in its possession
a portable radiation detection survey instrument capable of detecting dose rates
over the range 1 uSv (0.1 mrem) per hour to 1 mSv (100 mRem) per hour and a portable
radiation measurement survey instrument capable of measuring dose rates over the
range 10 uSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The instruments must
be operable and calibrated in accordance with OAR 333-116-0170.

A licensee authorized to use radioactive material as a sealed source for diagnostic purposes must have available for use a portable radiation detection survey instrument capable of detecting dose rates over the range one uSv (0.1 mrem) per hour to 100 mrem (one mSv) per hour and a portable radiation measurement survey instrument capable of measuring dose rates over the range ten uSv (1 mrem) per hour to ten mSv (1000 mrem) per hour. The instrument must be operable and calibrated in accordance with OAR 333-116-0170.

A licensee must use only brachytherapy sources for therapeutic medical uses:

(1) As approved in the Sealed Source and Device Registry; or

(2) In research with an active Investigational Device Exemption (IDE) application accepted by the Food and Drug Administration and are manufactured, labeled, packaged and distributed under a specific license issued by the Nuclear Regulatory Commission or an Agreement State.

(1) Immediately after implanting sources in a patient or a human research subject, the licensee must make a survey to locate and account for all sources that have not been implanted.

(2) Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee must make a survey of the room and the patient or the human research subject with an appropriate radiation detection survey instrument to confirm that all sources have been removed.

(3) A licensee must retain a record of the surveys required by sections (1) and (2) of this rule in accordance with OAR 333-100-0057.

(1) The licensee must provide oral and written radiation safety instruction to all personnel caring for a patient receiving implant therapy. Refresher training must be provided at intervals not to exceed one year.

(2) To satisfy section (1) of this rule, the instruction must describe:

(a) Size and appearance of the brachytherapy sources;

(b) Safe handling and shielding instructions in case of a dislodged source;

(c) Procedures for patient control;

(d) Procedures for visitor control including both:

(A) Routine visitation to hospitalized individuals in accordance with OAR 333-120-0180(1)(a); and

(B) Visitation authorized in accordance with OAR 333-120-0180(3); and

(e) Procedures for notification of the Radiation Safety Officer or authorized user if the patient dies or has a medical emergency.

(3) A licensee must retain a record of individuals receiving instruction required by section (1) of this rule in accordance with OAR 333-100-0057. The record must contain a description of the instruction, the date of instruction and the name of the individual who gave the instruction.

(1) A licensee
must, for each patient or human research subject receiving implant therapy:

(a) Not
place the patient or human research subject in the same room with a patient or human
research subject who is not receiving radiation therapy;

(b) Post
the patient's or human research subject's door with a "Caution: Radioactive Materials"
sign and note on the door or in the patient's chart where and how long visitors
may stay in the patient's room;

(c) Authorize
visits by individuals under age 18 only on a case-by-case basis with the approval
of the authorized user after consultation with the Radiation Safety Officer;

(d) Promptly
after implanting the sources, survey the dose rates in contiguous restricted and
unrestricted areas with a radiation measurement survey instrument to demonstrate
compliance with OAR 333-120-0180 of these rules. Retain a record of each survey
in accordance with OAR 333-100-0057. Each record must include the time and date
of the survey, a sketch of the area or list of points surveyed, the measured dose
rate at several points expressed in microsieverts (mrem) per hour, the instrument
used to make the survey and the initials of the individual who made the survey;
and

(e) Instruct
the patient or human research subject and, where appropriate, the patient's or human
research subject's family, orally and in writing concerning radiation safety precautions
that will help to keep the radiation dose to household members and the public as
low as reasonably achievable before releasing the patient if the patient was administered
a permanent implant.

(2) A
licensee shall have applicable emergency response equipment available near each
treatment room to respond to a source:

(a) Dislodged
from the patient; and

(b) Lodged
within the patient following removal of the source applicators.

(3) A
licensee must notify the Radiation Safety Officer or authorized user immediately
if the patient or human research subject dies or has a medical emergency.

(1) Before the first medical use of a brachytherapy source on or after July 1, 2006, a licensee must have:

(a) Determined the source output or activity using a dosimetry system that meets the requirements of OAR 333-116-0560(1);

(b) Determined source positioning accuracy within applicators; and

(c) Used published protocols currently accepted by nationally recognized bodies to meet the requirements of section (1) of this rule.

(2) Instead of a licensee making its own measurements as required in this rule, the licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine that are made in accordance with section (1) of this rule.

(3) A licensee must mathematically correct the outputs or activities determined in section (1) of this rule for physical decay at intervals consistent with one percent physical decay.

(4) Only an authorized medical physicist must calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under section (1) of this rule.

(5) A licensee must retain a record of each calibration in accordance with OAR 333-100-0057. Each record must include:

(a) The date of the calibration;

(b) The manufacturer's name, model number, and serial number for the source and the instruments used to calibrate the source;

(c) The source output or activity;

(d) The source positioning accuracy within the applicators; and

(e) The name of the individual, the source manufacturer, or the calibration laboratory that performed the calibration.

(6) Records of decay of strontium-90 sources for ophthalmic treatments must maintain a record of the activity of a strontium-90 source for the life of the source. The record must include:

(1) Only an authorized medical physicist shall calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under OAR 333-116-0445.

(2) A licensee shall retain a record of the activity of each strontium-90 source in accordance with OAR 333-100-0057.

(1) Immediately after removing the last temporary implant source from a patient or human research subject, the licensee must make a radiation survey of the patient or human research subject with an appropriate radiation detection survey instrument to confirm that all sources have been removed. The licensee must not release from confinement for medical care a patient or human research subject treated by temporary implant until all sources have been removed.

(2) A licensee must retain a record of patient surveys which demonstrate compliance with section (1) of this rule in accordance with OAR 333-100-0057. Each record must include the date of the survey, the name of the patient, the dose rate from the patient expressed as Sv (mrem) per hour and measured within one meter from the patient and the initials of the individual who made the survey.

A licensee authorized
to use radioactive material for implant therapy must have in its possession a portable
radiation detection survey instrument capable of detecting dose rates over the range
1 uSv (0.1 mrem) per hour to 1 mSv (100 mRem)per hour and a portable radiation measurement
survey instrument capable of measuring dose rates over the range 10 uSv (1 mrem)
per hour to 10 mSv (1000 mrem) per hour. The instruments must be operable and calibrated
in accordance with OAR 333-116-0170.

(1) The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:

(2) In research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA and are manufactured, labeled, packaged and distributed under a specific license issued by the Nuclear Regulatory Commission or an Agreement State.

Other Medical Uses of Byproduct Material or Radiation from Byproduct Material

A licensee shall use byproduct or a radiation source not specifically addressed in OAR 333-116-0300 through 333-116-0480 in accordance with the manufacturer’s radiation safety and operating instructions.

(1) Only a person specifically licensed by the Nuclear Regulatory Commission or an Agreement State must install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source(s), reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s).

(2) Except for low dose-rate remote afterloader units, only a person specifically licensed by the Nuclear Regulatory Commission or an Agreement State must install, replace, relocate, or remove a sealed source or source contained in other remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units.

(3) For a low dose-rate remote afterloader unit, only a person specifically licensed by the Nuclear Regulatory Commission or an Agreement State or an authorized medical physicist must install, replace, relocate, or remove a sealed source(s) contained in the unit.

(4) A licensee must retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units in accordance with OAR 333-100-0057. For each installation, maintenance, adjustment and repair, the record must include the date, description of the service, and name(s) of the individual(s) who performed the work.

(a) Secure the unit, the console, the console keys, and the treatment room when not in use or unattended;

(b) Permit only individuals approved by the authorized user, Radiation Safety Officer, or authorized medical physicist to be present in the treatment room during treatment with the source(s);

(c) Prevent dual operation of more than one radiation producing device in a treatment room if applicable; and

(d) Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source(s) in the shielded position, or remove the patient or human research subject from the radiation field with controls from outside the treatment room. These procedures must include:

(A) Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;

(B) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and

(C) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the unit or console operates abnormally.

(2) A copy of the procedures required by subsection (1)(d) of this rule must be physically located at the unit console.

(3) A licensee must post instructions at the unit console to inform the operator of:

(a) The location of the procedures required by subsection (1)(d) of this rule; and

(b) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the unit or console operates abnormally.

(4) A licensee must provide instruction, initially and at least annually, to all individuals who operate the unit, as appropriate to the individual's assigned duties in:

(a) The procedures identified in subsection (1)(d) of this rule; and

(b) The operating procedures for the unit.

(5) A licensee must ensure that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, initially and at least annually.

(6) A licensee must retain a record of individuals receiving instruction required by section (4) of this rule in accordance with OAR 333-100-0057.

(7) A licensee must retain a copy of the procedures required by subsections (1)(d) and (4)(b) of this rule until the licensee no longer possesses the remote afterloader, teletherapy unit, or gamma stereotactic radiosurgery unit.

(b) Cause the source(s) to be shielded when an entrance door is opened; and

(c) Prevent the source(s) from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source(s) on-off control is reset at the console.

(3) A licensee must require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels have returned to ambient levels.

(4) Except for low-dose remote afterloader units, a licensee must construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation.

(5) For licensed activities where sources are placed within the patient's or human research subject's body, a licensee must only conduct treatments which allow for expeditious removal of a decoupled or jammed source.

(6) In addition to the requirements specified in sections (1) through (5) of this rule, a licensee must:

(A) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit to be physically present during the initiation of all patient treatments involving the unit; and

(B) An authorized medical physicist and either an authorized user or an individual, under the supervision of an authorized user, who has been trained to remove the source applicator(s) in the event of an emergency involving the unit, to be immediately available during continuation of all patient treatments involving the unit.

(b) For high dose-rate remote afterloader units, require:

(A) An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit; and

(B) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, to be physically present during continuation of all patient treatments involving the unit.

(c) For gamma stereotactic radiosurgery units, require an authorized user and an authorized medical physicist to be physically present throughout all patient treatments involving the unit.

(d) Notify the Radiation Safety Officer, or his/her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

(7) A licensee must have applicable emergency response equipment available near each treatment room to respond to a source:

A licensee authorized to use radioactive material in a teletherapy therapy unit must have in its possession either both a portable radiation detection survey instrument capable of detecting dose rates over the range one Sv (0.1 mrem) per hour to 100 mrem (one mSv) per hour and a portable radiation measurement survey instrument capable of measuring dose rates over the range ten Sv (1 mrem) per hour to ten mSv (1000 mrem) per hour. The instruments must be operable and calibrated in accordance with OAR 333-116-0170.

(1) A licensee must have in each teletherapy room a permanent radiation monitor capable of continuously monitoring beam status.

(2) Each radiation monitor must be capable of providing visible evidence of a teletherapy unit malfunction that results in an exposed or partially exposed source. The visible indicator of high radiation levels must be observable by an individual prior to entering the teletherapy room.

(3) Each radiation monitor must be equipped with a backup power supply separate from the power supply to the teletherapy unit. This backup power supply may be a battery system or other type of uninterruptible power supply (UPS).

(4) Each radiation monitor must be checked with a dedicated check source for proper operation each day before the teletherapy unit is used for treatment of patients.

(5) A licensee must maintain a record of the check required by section (4) of this rule until inspection by the Authority. The record must include the date of the check, notation that the monitor indicates when the source is exposed and the initials of the individual who performed the check.

(6) If a radiation monitor is inoperable, the licensee must require any individual entering the teletherapy room to use a survey instrument or audible alarm personal dosimeter to monitor for any malfunction of the source exposure mechanism that may result in an exposed or partially exposed source. The instrument or dosimeter must be checked with a dedicated check source for proper operation at the beginning of each day of use. The licensee must keep a record as described in section (4) of this rule.

(7) If a radiation monitor is inoperable, the licensee must require any individual entering the teletherapy room to use a survey instrument or audible alarm personal dosimeter to monitor for any malfunction of the source exposure mechanism. The instrument or dosimeter must be checked with a dedicated check source for proper operation at the beginning of each day of use. The licensee must keep a record as described in section (5) of this rule.

(8) A licensee must promptly repair or replace the radiation monitor if it is inoperable.

(1) Except for low dose-rate remote afterloader sources where the source output or activity is determined by the manufacturer, a licensee must have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions must be met.

(a) The system must have been calibrated using a system or source traceable to the National Institute of Standards and Technology (NIST) and published protocols accepted by nationally recognized bodies; or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration must have been performed within the previous two years and after any servicing that may have affected system calibration; or

(b) The system must have been calibrated within the previous four years; 18 to 30 months after that calibration, the system must have been intercompared at an intercomparison meeting with another dosimetry system that was calibrated within the past 24 months by the National Institute of Standards and Technology or by a calibration laboratory accredited by the AAPM. The intercomparison meeting must be sanctioned by a calibration laboratory or radiologic physics center accredited by the AAPM. The results of the intercomparison meeting must show that the calibration factor of the licensee's system had not changed by more than two percent. The licensee must not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating sealed sources for therapeutic units, the licensee must use a comparable unit with beam attenuators or collimators, as applicable, and sources of the same radionuclide as the source used at the licensee's facility.

(2) The licensee must have available for use a dosimetry system for spot-check output measurements, if applicable. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with section (1) of this rule. This comparison must have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in section (1) of this rule.

(3) The licensee must retain a record of each calibration, intercomparison and comparison for the duration of the license. For each calibration, intercomparison or comparison, the record must include the date, the model numbers and serial numbers of the instruments that were calibrated, intercompared or compared as required by sections (1) and (2) of this rule, the correction factors that were deduced, the names and credentials of the individuals who performed the calibration, intercomparison or comparison, and evidence that the intercomparison meeting was sanctioned by a calibration laboratory or radiologic physics center accredited by AAPM.

(1) A licensee authorized to use a teletherapy unit for medical use must perform full calibration measurements on each teletherapy unit:

(a) Before the first medical use of the unit; and

(b) Before medical use under the following conditions:

(A) Whenever spot-check measurements indicate that the output differs by more than five percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

(B) Following replacement of the radioactive source or following reinstallation of the teletherapy unit in a new location;

(C) Following any repair of the teletherapy unit that includes removal of the radioactive source or major repair of the components associated with the source exposure assembly; and

(c) At intervals not exceeding one year.

(2) To satisfy the requirement of section (1) of this rule, full calibration measurements must include determination of:

(a) The output within three percent for the range of field sizes and for the distance or range of distances used for medical use;

(b) The coincidence of the radiation field and the field indicated by the light beam localizing device;

(c) The uniformity of the radiation field and its dependence on the orientation of the useful beam;

(d) Timer accuracy, constancy, and linearity;

(e) On-off error; and

(f) The accuracy of all distance measuring and localization devices in medical use.

(3) A licensee must use the dosimetry system described in OAR 333-116-0560(1) to measure the output for one set of exposure conditions. The remaining radiation measurements required in subsection (2)(a) of this rule may then be made using a dosimetry system that indicates relative dose rates.

(4) A licensee must make full calibration measurements required by section (1) of this rule in accordance with published protocols accepted by nationally recognized bodies.

(5) A licensee must correct mathematically the outputs determined in subsection (2)(a) of this rule for physical decay for intervals not exceeding one month for cobalt-60 and intervals not exceeding six months for cesium-137, or at intervals consistent with one percent decay for all other nuclides.

(6) Full calibration measurements required by section (1) of this rule and physical decay corrections required by section (5) of this rule must be performed by a teletherapy or medical physicist certified to perform such measurements and named on the licensee's license or authorized by a license issued by the Nuclear Regulatory Commission or an Agreement State to perform such services.

(7) A licensee must retain a record of each calibration in accordance with OAR 333-100-0057. The record must include the date of the calibration, the manufacturer's name, model number, and serial number for both the teletherapy unit and the source, the model numbers and serial numbers of the instruments used to calibrate the teletherapy unit, tables that describe the output of the unit over the range of field sizes and for the range of distances used in radiation therapy, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, the measured timer accuracy for a typical treatment time, the calculated on-off error, the estimated accuracy of each distance measuring or localization device and the signature of the teletherapy physicist.

(3) A licensee must use the dosimetry system described in OAR 333-116-0560(1) to measure the output.

(4) A licensee must make full calibration measurements required by section (1) of this rule in accordance with published protocols accepted by nationally recognized bodies.

(5) In addition to the requirements for full calibrations for low dose-rate remote afterloader units in section (2) of this rule, a licensee must perform an autoradiograph of the source(s) to verify inventory and source(s) arrangement at intervals not exceeding one quarter.

(6) For low dose-rate remote afterloader units, a licensee may use measurements provided by the source manufacturer that are made in accordance with sections (1) through (5) of this rule.

(7) A licensee must mathematically correct the outputs determined in subsection (2)(a) of this rule for physical decay at intervals consistent with one percent physical decay.

(8) Full calibration measurements required by subsection (2)(a) of this rule and physical decay corrections required by subsection (2)(g) of this rule must be performed by the authorized medical physicist.

(9) A licensee must retain a record of each calibration in accordance with OAR 333-100-0057.

(1) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use must perform full calibration measurements on each unit:

(a) Before the first medical use of the unit;

(b) Before medical use under the following conditions:

(A) Whenever spot-check measurements indicate that the output differs by more than five percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

(B) Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and

(C) Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and

(c) At intervals not exceeding one year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet.

(2) To satisfy the requirement of subsection (1)(a) of this rule, full calibration measurements must include determination of:

(a) The output within +/-three percent;

(b) Relative helmet factors;

(c) Isocenter coincidence;

(d) Timer accuracy and linearity over the range of use;

(e) On-off error;

(f) Trunnion centricity;

(g) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

(h) Helmet microswitches;

(i) Emergency timing circuits; and

(j) Stereotactic frames and localizing devices (trunnions).

(3) A licensee must use the dosimetry system described in OAR 333-116-0560(1) to measure the output for one set of exposure conditions. The remaining radiation measurements required in subsection (2)(a) of this rule may be made using a dosimetry system that indicates relative dose rates.

(4) A licensee must make full calibration measurements required by section (1) of this rule must be performed in accordance with published protocols accepted by nationally recognized bodies.

(5) A licensee must mathematically correct the outputs determined in subsection (2)(a) of this rule at intervals not exceeding one month for cobalt-60 and at intervals consistent with one percent physical decay for all other radionuclides.

(6) Full calibration measurements required by section (1) of this rule and physical decay corrections required by section (5) of this rule must be performed by the authorized medical physicist.

(7) A licensee must retain a record of each calibration in accordance with OAR 333-100-0057.

(1) A licensee authorized to use teletherapy units for medical use must perform output spot-checks on each teletherapy unit at intervals not to exceed one month that include the determination of:

(a) Timer constancy, accuracy, and linearity over the range of use;

(b) On-off error;

(c) The coincidence of the radiation field and the field indicated by the light beam localizing device;

(d) The accuracy of all distance measuring and localization devices used for medical use;

(e) The output for one typical set of operating conditions measured with the dosimetry system described in OAR 333-116-0560; and

(f) The difference between the measurement made in section (1) of this rule and the anticipated output, expressed as a percentage of the anticipated value obtained at last full calibration corrected mathematically for physical decay.

(2) A licensee must use the dosimetry system described in OAR 333-116-0560 to make the measurement required in section (1) of this rule.

(3) A licensee must perform measurements required by section (1) of this rule in accordance with procedures established by the teletherapy or medical physicist. That individual is not required to actually perform the output spot-check measurements.

(4) A licensee must have the teletherapy or medical physicist review the results of each output spot-check within 15 days of each measurement. The teletherapy or medical physicist must promptly notify the licensee in writing of the results of each output spot-check. The licensee must keep a copy of each written notification in accordance with OAR 333-100-0057.

(5) A licensee authorized to use a teletherapy unit for medical use must perform safety spot-checks of each teletherapy facility at intervals not to exceed one month and after each source installation to assure proper operation of:

(a) Electrical interlocks at each teletherapy room entrance;

(b) Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism;

(c) Beam condition indicator lights on the teletherapy unit, on the control console and in the facility;

(d) Viewing systems;

(e) Treatment room doors from inside and outside the treatment room; and

(6) A licensee must lock the control console in the "off" position if any door interlock malfunctions. No licensee must use the unit until the interlock system is repaired unless specifically authorized by the Authority.

(7) A licensee must promptly repair any system identified in section (5) of this rule that is not operating properly.

(8) A licensee must retain a record of each spot-check required by sections (1) and (5) of this rule in accordance with OAR 333-100-0057. The record must include, the date of the spot-check, the manufacturer's name, model number and serial number for both the teletherapy unit and source, the manufacturer's name, model number and serial number of the instrument used to measure the output of the teletherapy unit, the measured timer accuracy, the calculated on-off error, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, the measured timer accuracy for a typical treatment time, the calculated on-off error, the estimated accuracy of each distance measuring or localization device, the difference between the anticipated output and the measured output, notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system and doors and the signature of the individual who performed the periodic spot-check.

(1) A licensee authorized to use a remote afterloader unit for medical use must perform spot-checks of each remote afterloader facility and on each unit:

(a) Before the first use of a high dose-rate, medium dose-rate, or pulsed dose-rate remote afterloader unit on a given day;

(b) Before each patient treatment with a low dose-rate remote afterloader unit; and

(c) After each source installation.

(2) A licensee must perform the measurements required by section (1) of this rule in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot check measurements.

(3) A licensee must have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist must notify the licensee as soon as possible in writing of the results of each spot-check.

(4) To satisfy the requirements of section (1) of this rule, spot-checks must, at a minimum, assure proper operation of:

(5) If the results of the checks required in section (4) of this rule indicate the malfunction of any system, a licensee must lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(6) A licensee must retain a record of each check required by section (4) of this rule in accordance with OAR 333-100-0057. The record must include, as applicable:

(a) The date of the spot-check;

(b) The manufacturers name, model number for the remote afterloader and source;

(a) Check
survey instruments before medical use at each address of use or on each day of use,
whichever is more frequent; and

(b) Account
for all sources before departure from a client's address of use.

(2) In
addition to the periodic spot-checks required by OAR 333-116-0583, a licensee authorized
to use mobile afterloaders for medical use must perform checks on each remote afterloader
unit before use at each address of use. At a minimum, checks must be made to verify
the operation of:

(a) Electrical
interlocks on treatment area access points;

(b) Source
exposure indicator lights on the remote afterloader unit, on the control console,
and in the facility;

(g) Radiation
monitors used to indicate whether the source has returned to a safe shielded position.

(3) In
addition to the requirements for checks in section (2) of this rule, a licensee
must ensure overall proper operation of the remote afterloader unit by conducting
a simulated cycle of treatment before use at each address of use.

(4) If
the results of the checks required in section (2) of this rule indicate the malfunction
of any system, a licensee must lock the control console in the off position and
not use the unit except as may be necessary to repair, replace, or check the malfunctioning
system.

(5) A
licensee must retain a record of each check required by section (2) of this rule
in accordance with OAR 333-100-0057. The record must include:

(a) The
date of the check;

(b) The
manufacturer's name, model number, and serial number of the remote afterloader unit;

(c) Notations
accounting for all sources before the licensee departs from a facility;

(1) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use must perform spot-checks of each gamma stereotactic radiosurgery facility and on each unit:

(a) Monthly;

(b) Before the first use of the unit on a given day; and

(c) After each source installation.

(2) A licensee must:

(a) Perform the measurements required by section (1) of this rule in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot check measurements.

(b) Have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist must notify the licensee as soon as possible in writing of the results of each spot-check.

(3) To satisfy the requirements of subsection (1)(a) of this rule, spot-checks must, at a minimum:

(a) Assure proper operation of:

(A) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

(B) Helmet microswitches;

(C) Emergency timing circuits; and

(D) Stereotactic frames and localizing devices (trunnions).

(b) Determine:

(A) The output for one typical set of operating conditions measured with the dosimetry system described in OAR 333-116-0560;

(B) The difference between the measurement made in paragraph (3)(b)(A) of this rule and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay);

(C) Source output against computer calculation;

(D) Timer accuracy and linearity over the range of use;

(E) On-off error; and

(F) Trunnion centricity.

(4) To satisfy the requirements of subsections (1)(b) and (1)(c) of this rule, spot-checks must assure proper operation of:

(b) Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility;

(c) Viewing and intercom systems;

(d) Timer termination;

(e) Radiation monitors used to indicate room exposures; and

(f) Emergency off buttons.

(5) A licensee must arrange for the repair of any system identified in section (3) of this rule that is not operating properly as soon as possible.

(6) If the results of the checks required in section (4) of this rule indicate the malfunction of any system, a licensee must lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(7) A licensee must retain a record of each check required by sections (3) and (4) of this rule in accordance with OAR 333-100-0057. The record must include:

(a) The date of the spot-check;

(b) The manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit;

(c) An assessment of timer linearity and accuracy;

(d) The calculated on-off error;

(e) A determination of trunnion centricity;

(f) The difference between the anticipated output and the measured output;

(1) In addition to the survey requirement in OAR 333-120-0200, a person licensed under this rule must make surveys to ensure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the source(s) in the shielded position do not exceed the levels stated in the Sealed Source and Device Registry.

(2) The licensee must make the survey required by section (1) of this rule at installation of a new source and following repairs to the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s).

(3) A licensee must retain a record of the radiation surveys required by section (1) of this rule for the duration of use of the unit. The record must include:

(a) The date of the measurements;

(b) The manufacturer's name, model number and serial number of the treatment unit, source, and instrument used to measure radiation levels;

(c) Each dose rate measured around the source while the unit is in the off position and the average of all measurements; and

(1) A licensee must have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during source replacement or at intervals not to exceed five years, whichever comes first, to assure proper functioning of the source exposure mechanism.

(2) This inspection and servicing may only be performed by persons specifically licensed to do so by the Nuclear Regulatory Commission or an Agreement State.

(3) If the results of the checks required in section (1) of this rule indicate the malfunction of any system, the licensee must lock the control console in the "off" position and not use the unit except as may be necessary to repair, replace or check the malfunctioning system.

(4) A licensee must retain, in accordance with OAR 333-100-0057, a record of the facility checks following installation of a source. The record must include notations indicating the operability of each entrance door interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system and doors and the signature of the Radiation Safety Officer. In addition each record must contain:

(a) The inspector's radioactive materials license number;

(b) The date of inspection;

(c) The manufacturer's name and model number and serial number of both the treatment unit and source;

(d) A list of components inspected and serviced, and the type of service; and

The licensee must perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:

Modification of Teletherapy Unit or Room Before Beginning a Treatment Program

(1) If the survey required by OAR 333-116-0590 indicates that any individual member of the public is likely to receive a dose in excess of the limits specified in OAR 333-120-0180, before beginning the treatment program the licensee must:

(a) Either equip the unit with stops or add additional radiation shielding to ensure compliance with OAR 333-120-0180;

(b) Perform the survey required by OAR 333-116-0590 again; and

(c) Include in the report required by OAR 333-116-0620 the results of the initial survey, a description of the modification made to comply with subsection (1)(a) of this rule, and the results of the second survey.

(2) As an alternative to the requirements set out in subsection (1)(a) of this rule a licensee may request a license amendment under OAR 333-120-0180(3) that authorizes radiation levels in unrestricted areas greater than those permitted by 333-120-0180(1). A licensee may not begin the treatment program until the license amendment has been issued.

A licensee must furnish a copy of the records required in OAR 333-116-0590, 333-116-0600, 333-116-0610 and the output from the teletherapy source expressed as rem (Sv) per hour at one meter from the source and determined during the full calibration required in OAR 333-116-0570 to the Authority within 30 days following completion of the action that initiated the record requirement.

Except as provided
in OAR 333-116-0740, the licensee shall require an individual fulfilling the responsibilities
of the Radiation Safety Officer as provided in OAR 333-116-0090 to be an individual
who:

(1) Is certified
by a specialty board whose certification process has been recognized by the Commission
or an Agreement State and who meets the requirements in sections (4) and (5) of
this rule. (The names of board certifications which have been recognized by the
Commission or an Agreement State are posted on the NRC's webpage.) To have its certification
process recognized, a specialty board shall require all candidates for certification
to:

(a)(A) Hold
a bachelor's or graduate degree from an accredited college or university in physical
science or engineering or biological science with a minimum of 20 college credits
in physical science;

(B) Have
five or more years of professional experience in health physics (graduate training
may be substituted for no more than two years of the required experience) including
at least three years in applied health physics; and

(C) Pass
an examination administered by diplomates of the specialty board, which evaluates
knowledge and competence in radiation physics and instrumentation, radiation protection,
mathematics pertaining to the use and measurement of radioactivity, radiation biology,
and radiation dosimetry; or

(b)(A) Hold
a master's or doctor's degree in physics, medical physics, other physical science,
engineering, or applied mathematics from an accredited college or university;

(B) Have
two years of full-time practical training and supervised experience in medical physics:

(i) Under
the supervision of a medical physicist who is certified in medical physics by a
specialty board recognized by the Commission or an Agreement State; or

(ii) In clinical
nuclear medicine facilities providing diagnostic and therapeutic services under
the direction of physicians who meet the requirements for authorized users in OAR
333-116-0670, 333-116-0680 or 333-116-0740;

(C) Pass
an examination, administered by diplomates of the specialty board, that assesses
knowledge and competence in clinical diagnostic radiological or nuclear medicine
physics and in radiation safety; or

(2) Has completed
a structured educational program consisting of 200 hours of classroom and laboratory
training as follows:

(a) Radiation
physics and instrumentation;

(b) Radiation
protection;

(c) Mathematics
pertaining to the use and measurement of radioactivity;

(d) Radiation
biology;

(e) Radiopharmaceutical
chemistry;

(f) Radiation
dosimetry; and

(g) One year
of full time experience in radiation safety at a medical institution under the supervision
of the individual identified as the Radiation Safety Officer on an Authority, Agreement
State, Licensing State or U.S. Nuclear Regulatory Commission license that authorizes
similar type(s) of medical use of radioactive material involving the following:

(A) Shipping,
receiving, and performing related radiation surveys;

(B) Using
and performing checks for proper operation of instruments used to determine the
activity of dosages, survey meters, and instruments used to measure radionuclides;

(C) Securing
and controlling byproduct material;

(D) Using
administrative controls to avoid mistakes in the administration of byproduct material;

(E) Using
procedures to prevent or minimize radioactive contamination and using proper decontamination
procedures;

(F) Using
emergency procedures to control byproduct material; and

(G) Disposing
of radioactive material; or

(3)(a) Is
a medical physicist who has been certified by a specialty board whose certification
process has been recognized by the Nuclear Regulatory Commission or an Agreement
State under OAR 333-116-0905(1) and has experience in radiation safety for similar
types of use of byproduct material for which the licensee is seeking the approval
of the individual as Radiation Safety Officer and who meets the requirements in
sections (4) and (5) of this rule; or

(b) Is an
authorized user, authorized medical physicist, or authorized nuclear pharmacist
identified on the licensee's license and has experience with the radiation safety
aspects of similar types of use of byproduct material for which the individual has
Radiation Safety Officer responsibilities; and

(4) Has obtained
written attestation, signed by a preceptor Radiation Safety Officer, that the individual
has satisfactorily completed the requirements in section (5) and in paragraphs (1)(a)(A)
and (1)(b)(B) or paragraphs (1)(b)(A) and (1)(b)(B) or section (2), or subsections
(3)(a) or (3)(b) of this rule, and has achieved a level of radiation safety knowledge
sufficient to function independently as a Radiation Safety Officer for a medical
use licensee; and

(5) Has training
in the radiation safety, regulatory issues, and emergency procedures for the types
of use for which a licensee seeks approval. This training requirement may be satisfied
by completing training that is supervised by a Radiation Safety Officer, authorized
medical physicist, authorized nuclear pharmacist, or authorized user, as appropriate,
who is authorized for the type(s) of use for which the licensee is seeking approval.

An individual identified as a Radiation Safety Officer on an Authority, Agreement State, Licensing State or U.S. Nuclear Regulatory Commission license on July 1, 2006 who oversees only the use of radioactive material for which the licensee was authorized on that date need not comply with the training requirements of OAR 333-116-0640.

Except as provided in OAR 333-116-0740,
the licensee shall require the authorized user of a radiopharmaceutical listed in
333-116-0300 to be a physician who:

(1) Is certified by a medical
specialty board whose certification process has been recognized by the Nuclear Regulatory
Commission or an Agreement State and who meets the requirements in section (4) of
this rule (The names of board certifications recognized by the NRC or an Agreement
State are posted on the NRC’s website). To have its certification process
recognized, a specialty board shall require all candidates for certification to:

(a) Complete 60 hours of
training and experience in basic radionuclide handling techniques applicable to
the medical use of unsealed byproduct material for uptake, dilution, and excretion
studies. The training and experience must include paragraphs (3)(a)(A) through (3)(b)(F)
of this rule; and

(b) Pass an examination administered
by diplomats of the specialty board that assesses knowledge and competence in radiation
safety, radionuclide handling and quality control; or

(2) Is an authorized user
under OAR 333-116-0670, 333-116-0680, or equivalent Nuclear Regulatory Commission
or Agreement State requirements; or

(3) Has completed 60 hours
of training and experience, including a minimum of eight hours of classroom and
laboratory training, in basic radionuclide handling techniques and radiation safety
applicable to the medical use of unsealed byproduct material for uptake, dilution,
and excretion studies. The training and experience must include:

(a) Classroom and laboratory
training in the following areas:

(A) Radiation physics and
instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining
to the use and measurement of radioactivity;

(D) Chemistry of byproduct
material for medical use; and

(E) Radiation biology; and

(b) Work experience, under
the supervision of an authorized user who meets the requirements in OAR 333-116-0660,
333-116-0670, 333-116-0680 and 333-116-0740 or Nuclear Regulatory Commission or
equivalent Agreement State requirements, involving:

(D) Using administrative
controls to prevent a medical event involving the use of unsealed byproduct material;

(E) Using procedures to contain
spilled byproduct material safely and using proper decontamination procedures; and

(F) Administering dosages
of radiopharmaceutical drugs to patients or human research subjects; and

(4) Has obtained written
attestation, signed by a preceptor authorized user who meets the requirements, in
OAR 333-116-0740, 333-116-0660, 333-116-0670, or 333-116-0680, or Nuclear Regulatory
Commission or equivalent Agreement State requirements, that the individual has satisfactorily
completed the requirements in subsection (1)(a) or section (3) of this rule and
has achieved a level of competency sufficient to function independently as an authorized
user for the medical uses authorized under 333-116-0300.

Except as provided
in OAR 333-116-0740, the licensee shall require an authorized user of unsealed byproduct
material for the uses authorized under OAR 333-116-0320 to be a physician who:

(1) Is certified
by a medical specialty board whose certification process has been recognized by
the Commission or an Agreement State and who meets the requirements in section (4)
of this rule. (The names of board certifications that have been recognized by the
Commission or an Agreement State are posted on the NRC’s website). To have
its certification process recognized, a specialty board shall require all candidates
for certification to:

(a) Complete
700 hours of training and experience in basic radionuclide handling techniques and
radiation safety applicable to the medical use of unsealed byproduct material for
imaging and localization studies as described in subsection (3)(a) through paragraph
(2)(b)(G) of this rule; and

(b) Pass
an examination administered by diplomats of the specialty board, which assesses
knowledge and competence in radiation safety, radionuclide handling and quality
control; or

(2) Is an
authorized user under OAR 333-116-0680 and meets the requirements in OAR 333-116-0670(3)(b)(G)
or equivalent Nuclear Regulatory Commission or Agreement State requirements; or

(3) Has completed
700 hours of training and experience, including a minimum of 80 hours of classroom
and laboratory training in basic radionuclide handling techniques and radiation
safety applicable to the medical use of unsealed byproduct material for imaging
and localization studies.

(a) The training
and experience must include at a minimum classroom and laboratory training in the
following areas:

(A) Radiation
physics and instrumentation;

(B) Radiation
protection;

(C) Mathematics
pertaining to the use and measurement of radioactivity;

(D) Chemistry
of byproduct material for medical use; and

(E) Radiation
biology; and

(b) Work
experience, under the supervision of an authorized user, who meets the requirements
in this rule or OAR 333-116-0670, 333-116-0680, 333-116-0740 and 333-116-0670(3)(b)(G)
or equivalent Nuclear Regulatory Commission or Agreement State requirements, involving:

(F) Administering
dosages of radioactive drugs to patients or human research subjects; and

(G) Eluting
generator systems appropriate for preparation of radiopharmaceutical drugs for imaging
and localization studies, measuring and testing the eluate for radionuclidic purity,
and processing the eluate with reagent kits to prepare labeled radiopharmaceutical
drugs; and

(4) Has obtained
written attestation, signed by a preceptor authorized user who meets the requirements
in this rule or OAR 333-116-0670(3)(b)(G), 333-116-0680, 333-116-0740 or equivalent
Nuclear Regulatory Commission or Agreement State requirements, that the individual
has satisfactorily completed the requirements in subsection (1)(a) or section (3)
of this rule and has achieved a level of competency sufficient to function independently
as an authorized user for the medical uses authorized under OAR 333-116-0300 and
333-116-0320. .

Except as provided in OAR 333-116-0740,
the licensee must require an authorized user of unsealed byproduct material for
the uses authorized under 333-116-0360 to be a physician who:

(1)(a) Is certified by a
medical specialty board whose certification process has been recognized by the NRC
or an Agreement State and who meets the requirements in paragraph (2)(b)(F) and
subsection (2)(c) of this rule. (Specialty boards whose certification processes
have been recognized by the NRC or an Agreement State shall be posted on the NRC's
webpage). To be recognized, a specialty board shall require all candidates for certification
to:

(b) Successfully complete
residency training in a radiation therapy or nuclear medicine training program or
a program in a related medical specialty. These residency training programs must
include 700 hours of training and experience as described in subsection (2)(a) through
paragraph (2)(b)(E). Eligible training programs must be approved by the Residency
Review Committee of the Accreditation Council for Graduate Medical Education, the
Royal College of Physicians and Surgeons of Canada, or the Committee on Post-Graduate
Training of the American Osteopathic Association; and

(b) Pass an examination,
administered by diplomats of the specialty board, which tests knowledge and competence
in radiation safety, radionuclide handling, quality assurance, and clinical use
of unsealed byproduct material for which a written directive is required; or

(2) Has completed 700 hours
of training and experience, including a minimum of 200 hours of classroom and laboratory
training in basic radionuclide handling techniques applicable to the medical use
of unsealed byproduct material requiring a written directive. The training and experience
must include:

(a) Classroom and laboratory
training in the following areas:

(A) Radiation physics and
instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining
to the use and measurement of radioactivity;

(D) Chemistry of byproduct
material for medical use; and

(E) Radiation biology; and

(b) Work experience, under
the supervision of an authorized user who meets the requirements in OAR 333-116-0740,
and sections (1) and (2) of this rule, or NRC or equivalent Agreement State requirements.
A supervising authorized user, who meets the requirements in section (2) of this
rule, must have experience in administering dosages in the same dosage category
or categories as given in OAR 333-116-0680(2)(b)(F) as the individual requesting
authorized user status. The work experience must involve:

(D) Using administrative
controls to prevent a medical event involving the use of unsealed byproduct material;

(E) Using procedures to contain
spilled byproduct material safely and using proper decontamination procedures; and

(F) Administering dosages
of radiopharmaceutical drugs to patients or human research subjects involving a
minimum of three cases in each of the following categories for which the individual
is requesting authorized user status:

(i) Oral administration of
less than or equal to 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131;

NOTE: Experience with at least three
cases in subparagraph (ii) also satisfies the requirement in subparagraph (i).

(iii) Parenteral administration of any
beta emitter or a photon-emitting radionuclide with a photon energy less than 150
keV; or

(iv) Parenteral administration
of any other radionuclide; and

(c) Has obtained written
attestation that the individual has satisfactorily completed the requirements in
sections (1) and (2) and paragraph (2)(b)(F) of this rule, and has achieved a level
of competency sufficient to function independently as an authorized user for the
medical uses authorized under OAR 333-116-0360. The written attestation must be
signed by a preceptor authorized user who meets the requirements in 333-116-0740,
333-116-0680 or equivalent NRC or Agreement State requirements. The preceptor authorized
user, who meets the requirements in section (2) of this rule, must have experience
in administering dosages in the same dosage category or categories as given in 333-116-0680(2)(b)(F)(i),
(ii), (iii), or (iv) as the individual requesting authorized user status.

Training for the Oral Administration
of Sodium Iodide I-131 Requiring a Written Directive in Quantities Less Than or
Equal to 1.22 Gigabecquerels (33 millicuries)

Except as provided in OAR 333-116-0740,
the licensee shall require an authorized user for the oral administration of sodium
iodide I-131 requiring a written directive and the total treatment quantity is less
than or equal to 1.22 Gigabecquerels (33 millicuries), to be a physician who:

(1) Is certified by a medical
specialty board whose certification process includes all of the requirements in
section (3) of this rule and whose certification has been recognized by the NRC
or an Agreement State and who meets the requirements in subsection (3)(c) of this
rule. (The names of board certifications which have been recognized by the NRC or
an Agreement State are posted on the NRC’s webpage); or

(2) Is an authorized user
under OAR 333-116-0680 for uses listed in 333-116-0680(2)(b)(F)(i) or (ii) or 333-116-0687,
or equivalent Agreement State requirements; or

(3) Has successfully completed
80 hours of classroom and laboratory training, applicable to the medical use of
sodium iodide I-131 for procedures requiring a written directive.

(a) The training must include:

(A) Radiation physics and
instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining
to the use and measurement of radioactivity;

(D) Chemistry of byproduct
material for medical use; and

(E) Radiation biology; and

(b) Has work experience,
under the supervision of an authorized user who meets the requirements in OAR 333-116-0680,
333-116-0683, 333-116-0687, 333-116-0740 or equivalent NRC or Agreement State requirements.
A supervising authorized user who meets the requirements in 333-116-0680(2) must
have experience in administering dosages as specified in 333-116-0680(2)(b)(F)(i)
or (ii). The work experience must involve:

(D) Using administrative
controls to prevent a medical event involving the use of byproduct material;

(E) Using procedures to contain
spilled byproduct material safely and using proper decontamination procedures; and

(F) Administering dosages
to patients or human research subjects, that includes at least three cases involving
the oral administration of less than or equal to 1.22 Gigabecquerels (33 millicuries)
of sodium iodide I-131; and

(c) Has obtained written
attestation that the individual has satisfactorily completed the requirements in
subsections (3)(a) and (3)(b) of this rule and has achieved a level of competency
sufficient to function independently as an authorized user for medical uses authorized
under OAR 333-116-0360. The written attestation must be signed by a preceptor authorized
user who meets the requirements in OAR 333-116-0740, 333-116-0680, 333-116-0683,
333-116-0687 or equivalent NRC or Agreement State requirements. A preceptor authorized
user, who meets the requirement in OAR 333-116-0680(2), must also have experience
in administering dosages as specified in OAR 333-116-0680(2)(b)(F)(i) or (ii).

Training for Oral Administration
of Sodium Iodide I-131 Requiring a Written Directive in Quantities Greater than
1.22 Gigabecquerels (33 millicuries)

Except as provided in OAR 333-116-0740,
the licensee must require an authorized user for the oral administration of sodium
iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels
(33 millicuries), to be a physician who:

(1) Is certified by a medical
specialty board whose certification process includes all of the requirements in
subsection (3)(a) and (3)(b) of this rule and whose certification has been recognized
by the NRC or an Agreement State, and who meets the requirements in subsection (3)(c)
of this rule. (The names of board certifications which have been recognized by the
NRC or an Agreement State are posted on the NRC's webpage); or

(2) Is an authorized user
under OAR 333-116-0680 for uses listed in OAR 333-116-0680(2)(b)(F)(ii), or equivalent
NRC or Agreement State requirements; or

(3) Has successfully completed
80 hours of classroom and laboratory training, applicable to the medical use of
sodium iodide I-131 for procedures requiring a written directive.

(a) The training must include:

(A) Radiation physics and
instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining
to the use and measurement of radioactivity;

(D) Chemistry of byproduct
material for medical use; and

(E) Radiation biology; and

(b) Has work experience,
under the supervision of an authorized user who meets the requirements in OAR 333-116-0680,
333-116-0687, 333-116-0740, or equivalent NRC or Agreement State requirements. A
supervising authorized user, who meets the requirements in OAR 333-116-0680(2),
must have experience in administering dosages as specified in OAR 333-116-0680(2)(b)(F)(ii).
The work experience must involve:

(D) Using administrative
controls to prevent a medical event involving the use of byproduct material;

(E) Using procedures to contain
spilled byproduct material safely and using proper decontamination procedures; and

(F) Administering dosages
to patients or human research subjects, that includes at least three cases involving
the oral administration of greater than 1.22 Gigabecquerels (33 millicuries) of
sodium iodide I-131; and

(c) Has obtained written
attestation that the individual has satisfactorily completed the requirements in
subsections (3)(a) and (3)(b) of this rule, and has achieved a level of competency
sufficient to function independently as an authorized user for medical uses authorized
under OAR 333-116-0360. The written attestation must be signed by a preceptor authorized
user who meets the requirements in 333-116-0680, 333-116-0687, 333-116-0740, or
equivalent Agreement State requirements. A preceptor authorized user, who meets
the requirements in 333-116-0680(2), must have experience in administering dosages
as specified in 333-116-0680(2)(b)(F)(ii).

Except as provided in OAR 333-116-0740,
the licensee must require the authorized user using manual brachytherapy sources
specified in OAR 333-116-0420 for therapy to be a physician who:

(1) Is certified by a medical
specialty board whose certification process has been recognized by the NRC or an
Agreement State, and who meets the requirements in subsection (2)(d) of this rule.
(The names of board certifications which have been recognized by the NRC or an Agreement
State are posted on the NRC’s webpage.) To have its certification process
recognized, a specialty board shall require all candidates for certification to:

(a) Successfully complete
a minimum of three years of residency training in a radiation oncology program approved
by the Residency Review Committee of the Accreditation Council for Graduate Medical
Education or the Royal College of Physicians and Surgeons of Canada or the Committee
on Post-Graduate Training of the American Osteopathic Association; and

(b) Pass an examination,
administered by diplomats of the specialty board, that tests knowledge and competence
in radiation safety, radionuclide handling, treatment planning, quality assurance
and clinical use of manual brachytherapy; or

(2) Has completed a structured
educational program in basic radionuclide handling techniques applicable to the
use of manual brachytherapy sources that includes:

(a) 200 hours of classroom
and laboratory training in the following areas:

(A) Radiation physics and
instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining
to the use and measurement of radioactivity; and

(D) Radiation biology; and

(b) 500 hours of work experience,
under the supervision of an authorized user who meets the requirements in this rule,
OAR 333-116-0740 or equivalent NRC or Agreement State requirements at a medical
institution, involving:

(E) Using administrative
controls to prevent a medical event involving the use of byproduct material; and

(F) Using emergency procedures
to control byproduct material; and

(c) Has completed three years
of supervised clinical experience in radiation oncology, under an authorized user
who meets the requirements in OAR 333-116-0740, 333-116-0690, or equivalent NRC
or Agreement State requirements, as part of a formal training program approved by
the Residency Review Committee for Radiation Oncology of the Accreditation Council
for Graduate Medical Education, or the Royal College of Physicians and Surgeons
of Canada, or the Committee on Postdoctoral Training of the American Osteopathic
Association. This experience may be obtained concurrently with the supervised work
experience required by subsection (2)(b) of this rule; and

(d) Has obtained written
attestation, signed by a preceptor authorized user who meets the requirements in
OAR 333-116-0740, 333-116-0690, or equivalent NRC or Agreement State requirements,
that the individual has satisfactorily completed the requirements in subsection
(1)(a), or subsections (2)(a), (2)(b) and (2)(c) of this rule and has achieved a
level of competency sufficient to function independently as an authorized user of
manual brachytherapy sources for the medical uses authorized under 333-116-0420.

Except as provided in OAR 333-116-0740,
the licensee must require the authorized user using only strontium-90 for ophthalmic
radiotherapy to be a physician who:

(1) Is an authorized user
under OAR 333-116-0690 or equivalent Nuclear Regulatory Commission or Agreement
State requirements; or

(2) Has completed 24 hours
of classroom and laboratory training applicable to the medical use of strontium-90
for ophthalmic radiotherapy.

(a) The training must include:

(A) Radiation physics and
instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining
to the use and measurement of radioactivity; and

(D) Radiation biology; and

(b) Supervised clinical training
in ophthalmic radiotherapy under the supervision of an authorized user at a medical
institution that includes the use of strontium-90 for the ophthalmic treatment of
five individuals. This supervised clinical training must involve:

(A) Examination of each individual
to be treated;

(B) Calculation of the dose
to be administered;

(C) Administration of the
dose;

(D) Follow up and review
of each individual's case history; and

(E) Has obtained written
attestation, signed by a preceptor authorized user who meets the requirements in
OAR 333-116-0740, 333-116-0690, 333-116-0700, or equivalent Nuclear Regulatory Commission
or Agreement State requirements, that the individual has satisfactorily completed
the requirements in section (2) of this rule and has achieved a level of competency
sufficient to function independently as an authorized user of strontium-90 for ophthalmic
use.

Except as provided in OAR 333-116-0740 the licensee must require the authorized user using a sealed source in a device specified in OAR 333-116-0400 to be a physician, dentist or podiatrist who:

(1) Is certified in:

(a) Radiology, diagnostic radiology with special competence in nuclear radiology, radiation oncology or therapeutic radiology by the American Board of Radiology; or

(b) Nuclear medicine by the American Board of Nuclear Medicine; or

(c) Diagnostic radiology or radiology by the American Osteopathic Board of Radiology.

(2) Has completed eight hours of instruction in basic radioisotope handling techniques specifically applicable to the use of the device. To satisfy the requirement for instruction, the training must include:

(a) Radiation physics, mathematics pertaining to the use and measurement of radioactivity and instrumentation;

(b) Radiation biology;

(c) Radiation protection and training in the use of the device for the purposes authorized by the license; and

Training for the Parenteral Administration
of Unsealed Byproduct Material Requiring a Written Directive

Except as provided in OAR 333-116-0740,
the licensee shall require an authorized user for the parenteral administration
requiring a written directive, to be a physician who:

(1) Is an authorized user
under OAR 333-116-0680 for uses listed in 333-116-0680(2)(b)(F)(iii) or 333-116-0680(2)(b)(F)(iv)
or equivalent Agreement State requirements; or

(2) Is an authorized user
under OAR 333-116-0690 or 333-116-0720, or equivalent Agreement State or Nuclear
Regulatory Commission requirements and who meets the requirements in section (4)
of this rule; or

(3) Is certified by a medical
specialty board whose certification process has been recognized by the Nuclear Regulatory
Commission or an Agreement State under OAR 333-116-0690 or 333-116-0720, and who
meets the requirements in section (4) of this rule.

(4) Has successfully completed
80 hours of classroom and laboratory training, applicable to parenteral administrations,
for which a written directive is required, of any beta emitter, or any photon-emitting
radionuclide with a photon energy less than 150 keV, or parenteral administration
of any other radionuclide for which a written directive is required.

(a) The training must include:

(A) Radiation physics and
instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining
to the use and measurement of radioactivity;

(D) Chemistry of byproduct
material for medical use; and

(E) Radiation biology; and

(b) Has work experience,
under the supervision of an authorized user who meets the requirements in OAR 333-116-0680,
333-116-0715, 333-116-0740 or equivalent Nuclear Regulatory Commission or Agreement
State requirements, in the parenteral administration, for which a written directive
is required, of any beta emitter, or any photon-emitting radionuclide with a photon
energy less than 150 keV, or parenteral administration of any other radionuclide
for which a written directive is required. A supervising authorized user who meets
the requirements in 333-116-0680 must have experience in administering dosages as
specified in 333-116-0680(2)(b)(F)(iii) or 333-116-0680(2)(b)(F)(iv). The work experience
must involve:

(D) Using administrative
controls to prevent a medical event involving the use of unsealed byproduct material;

(E) Using procedures to contain
spilled byproduct material safely, and using proper decontamination procedures;
and

(F) Administering dosages
to patients or human research subjects, that include at least three cases involving
the parenteral administration, for which a written directive is required, of any
beta emitter, or any photon-emitting radionuclide with a photon energy less than
150 keV and at least three cases involving the parenteral administration of any
other radionuclide, for which a written directive is required; and

(c) Has obtained written
attestation that the individual has satisfactorily completed the requirements in
sections (2) or (3) of this rule, and has achieved a level of competency sufficient
to function independently as an authorized user for the parenteral administration
of unsealed byproduct material requiring a written directive. The written attestation
must be signed by a preceptor authorized user who meets the requirements in OAR
333-116-0680, 333-116-0715, 333-116-0740 or equivalent Agreement State requirements.
A preceptor authorized user, who meets the requirements in 333-116-0680, must have
experience in administering dosages as specified in 333-116-0680(2)(b)(F)(iii) or
333-116-0680(2)(b)(F)(iv).

Except as provided
in OAR 333-116-0740, the licensee must require the authorized user of a sealed source
specified in OAR 333-116-0480 to be a physician who:

(1) Is certified
by a medical specialty board whose certification process has been recognized by
the Nuclear Regulatory Commission (NRC) or an Agreement State and who meets the
requirements in subsection (2)(c) and section (3) of this rule. (The names of board
certifications which have been recognized by the Commission or an Agreement State
are posted on the NRC's webpage.) To have its certification process recognized,
a specialty board shall require all candidates for certification to:

(a) Successfully
complete a minimum of three years of residency training in a radiation therapy program
approved by the Residency Review Committee of the Accreditation Council for Graduate
Medical Education or the Royal College of Physicians and Surgeons of Canada or the
Committee on Post-Graduate Training of the American Osteopathic Association; and

(b) Pass
an examination, administered by diplomates of the specialty board, which tests knowledge
and competence in radiation safety, radionuclide handling, treatment planning, quality
assurance, and clinical use of stereotactic radiosurgery, remote afterloaders and
external beam therapy; or

(2) Has completed
a structured educational program in basic radionuclide techniques applicable to
the use of a sealed source in a therapeutic medical unit:

(a) Which
includes the following:

(A) 200 hours
of classroom and laboratory training in the following areas:

(i) Radiation
physics and instrumentation;

(ii) Radiation
protection;

(iii) Mathematics
pertaining to the use and measurement of radioactivity; and

(iv) Radiation
biology; and

(B) 500 hours
of work experience, under the supervision of an authorized user who meets the requirements
in OAR 333-116-0720, 333-116-0740 or equivalent Nuclear Regulatory Commission or
Agreement State requirements at a medical institution, involving:

(iii) Using
administrative controls to prevent a medical event involving the use of byproduct
material;

(iv) Implementing
emergency procedures to be followed in the event of the abnormal operation of the
medical unit or console;

(v) Checking
and using survey meters; and

(vi) Selecting
the proper dose and how it is to be administered; and

(b) Has completed
three years of supervised clinical experience in radiation therapy, under an authorized
user who meets the requirements in OAR 333-116-0720, 333-116-0740 or equivalent
Nuclear Regulatory Commission or Agreement State requirements, as part of a formal
training program approved by the Residency Review Committee for Radiation Oncology
of the Accreditation Council for Graduate Medical Education or the Royal College
of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of
the American Osteopathic Association. This experience may be obtained concurrently
with the supervised work experience required by paragraph (2)(a)(B) of this rule;
and

(c) Has obtained
written attestation that the individual has satisfactorily completed the requirements
in subsections (1)(a) or (2)(a) and (2)(b), and section (3) of this rule, and has
achieved a level of competency sufficient to function independently as an authorized
user of each type of therapeutic medical unit for which the individual is requesting
authorized user status. The written attestation must be signed by a preceptor authorized
user who meets the requirements in OAR 333-116-0720, 333-116-0740 or equivalent
Nuclear Regulatory Commission or Agreement State requirements for an authorized
user for each type of therapeutic medical unit for which the individual is requesting
authorized user status; and

(3) Has received
training in device operation, safety procedures, and clinical use for the type(s)
of use for which authorization is sought. This training requirement may be satisfied
by satisfactory completion of a training program provided by the vendor for new
users or by receiving training supervised by an authorized user or authorized medical
physicist, as appropriate, who is authorized for the type(s) of use for which the
individual is seeking authorization.

(2) Be certified by the American Board of Medical Physics in radiation oncology physics; or

(3) Hold a master's or doctor's degree in physics, biophysics, radiological physics or health physics and have completed one year of full time training in therapeutic radiological physics and also one year of full time work experience under the supervision of a teletherapy or brachytherapy physicist at a medical institution. To meet this requirement, the individual must have performed the tasks listed in OAR 333-116-0200, 333-116-0570, 333-116-0580 and 333-116-0590 under the supervision of a teletherapy or brachytherapy physicist during the year of work experience.

(1) An individual
identified as a Radiation Safety Officer, teletherapy or medical physicist, authorized
medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist
on a Nuclear Regulatory Commission or Agreement State license before July 1, 2006
need not comply with the training requirements of OAR 333-116-0640, 333-116-0905
or 333-116-0910.

(2) Practitioners
of the healing arts identified as authorized users for the human use of radioactive
material on an Authority, Nuclear Regulatory Commission or Agreement State or Licensing
State license before July 1, 2006 who perform only those methods of use for which
they were authorized on that date need not comply with the training requirements
OAR 333-116-0640, 333-116-0905, or 333-116-0910. .

(3) Individuals
who need not comply with training requirements as described in this rule may serve
as preceptors for, and supervisors of, applicants seeking authorization on licenses
for the same uses for which these individuals are authorized.

A physician who, before July 1, 1984, began a three month nuclear medicine training program approved by the Accreditation Council for Graduate Medical Education and has successfully completed the program is exempted from the requirements of OAR 333-116-0660 or 333-116-0670.

The training and experience specified in OAR 333-116-0640 through 333-116-0730 and OAR 333-116-0905 through 333-116-0915 must have been obtained within the seven years preceding the date of application or the individual must have had continuing education and experience since the required training and experience was completed.

(1) Each component of a PET facility (accelerator, radiopharmacy, and clinic) must be separately licensed pursuant to OAR 333-101-0005, 333-102-0200, 333-103-0005 or 333-103-0010.

(2) The licensee or registrant must receive applicable Authority authorization at least 30 days prior to the production of any accelerator-produced radioactive material or any change in accelerator configuration, shielding, location, room shielding or configuration, nuclide production method, ventilation systems, rabbit or other delivery systems, operating or emergency procedures, radiation safety personnel, authorized users or operators, or other applicable provisions authorized pursuant to these rules.

(1) Management must ensure that there is a qualified Radiation Safety Officer (RSO) who must oversee the radiation safety aspects of the PET facility and be responsible for radiation safety of the accelerator facility, pharmacy, and PET clinic.

(a) In the case of separate licenses for different components in a PET facility, there must be a cooperative consortium of management and radiation safety personnel that acts as directors for the facility.

(b) Management, whether singular or in consortium, must write a statement of authority and responsibility for all staff handling or controlling the production and use of PET isotopes.

(2) The RSO must be assisted by personnel specifically trained and designated for the area of concern, whether accelerator operation, pharmaceutical production, or PET clinic.

(1) The licensee must ensure that any radiopharmaceutical for which an Investigational New Drug (IND) status does not exist, or which must be used for research purposes in humans, is reviewed by an Institutional Review Board (IRB) or Human Subjects Review Board or Committee. The licensee must establish procedures, reviews, quality assurance, and emergency procedures for all procedures reviewed by the IRB. The IRB, the PET Radiation Safety Committee or subcommittee, and the PET or facility Radiation Safety Officer must review and approve any and all PET procedures, unless otherwise authorized in a radioactive materials license pursuant to OAR 333-102-0200.

(2) Transfers of radioisotopes must be in accordance with requirements in OAR 333-102-0330.

(1) Accelerators must meet all requirements of division 333-109. Shielded-room accelerators must be equipped with interlocks and personnel control; self-shielded accelerators must be shielded such that personnel access is prevented during operation.

(4) There must be an Understanding of Transfer (UOT) when isotopes are transferred from one licensee or entity to another for processing, specifying at what point control is transferred to personnel handling radiochemical production or radiopharmacy operation.

(5) Radiation surveys must be made prior to any accelerator operation or isotope production with a radiation survey instrument calibrated in accordance with requirements in OAR 333-116-0390. Periodic surveys must be done throughout times of operation to ensure that radiation levels meet all applicable requirements in division 333-120 (Radiation Protection Standards).

(6) Ventilation controls must be implemented to ensure compliance with all applicable local, state, and federal requirements. Controls must include monitoring of stacks and computer modeling of air emissions to confirm compliance with standards.

(7) Real-time (integrating) monitors must be used to confirm requirements in OAR 333-120-0100, 333-120-0160, 333-120-0170, and 333-120-0180.

(8) Contamination wipes for radioactive material must be made pursuant to requirements in OAR 333-116-0250;

(9) Dosimetry must address both gamma and beta doses in all areas of the facility. Licensees and registrants must monitor extremities to ensure compliance with OAR 333-120-0100. Bioassays, as defined in OAR 333-100-0005, are not required, but there must be evaluation of internal exposures, pursuant to OAR 333-120-0130, based on calculated releases and monitoring.

(6) Shielding around guide-bends, targets, hot-cells, purification manifolds, etc. must ensure that limits in OAR 333-120-0180 and 333-120-0190 have been met in all areas of beam and nuclide production.

(1) All preparations used in humans must meet the Oregon State Board of Pharmacy standards, as well as applicable federal Food and Drug Administration (FDA) requirements.

(a) All research products to be used in humans must be reviewed and approved by the licensee's or consortium Institutional Review Board (IRB).

(b) No research radiopharmaceutical must be used in a human being until its pyrogenicity and purity have been shown to meet applicable standards.

(2) Pharmacy or chemistry personnel must work directly under the supervision of a physician who meets the training criteria in OAR 333-116-0670.

(3) There must be no transfers between or among licensees unless there is a signed Memorandum or Understanding of Transfer. Such memorandum must preclude any transfers from one licensee entity to another if there is incomplete information, purity questions, or non-approval from the IRB.

(4) There must be a detailed description of the shielding and operation of the "black box" (hot cell).

(5) There must be operating and emergency, training, and survey procedures for ease of movement of the product within the pharmacy production area. Emergency procedures must address potential high dose rate emergencies such as stuck rabbit (transport container), pneumatic tube contamination, manifold leak or spill, hot cell emergency, or other incident.

(6) Equipment and procedures must include:

(a) Hood with continuous stack monitoring system and procedures to confirm air emission standards compliance;

(b) Remote handling equipment for very high dose rates (all handling must be done remotely);

(c) Dose calibration, system validation, and calibration standards, for all individual doses;

(d) Ba-133 must not be used as a calibration source;

(e) Dose calibrator linearity check using a positron emitter (beta shield must be evaluated to prevent interference with annihilation measurement);

Rubidium-82 generators require quality assurance procedures for equipment, patient injection, waiting area, imaging, and post-imaging care. There also must be a procedure for spills, and a handling procedure for liquid quality assurance sources for early model PET cameras. Dose calibration procedures are the same as in OAR 333-116-0850(6).

(4) Positron
Emission-Computed Tomography (PET/CT) or Single Photon Emission-Computed Tomography
(SPECT/CT) systems must be operated by technologists licensed by the Oregon Board
of Medical Imaging who are:

(5) The individuals
mentioned in section (4) of this rule must also have successfully completed appropriate
additional education and training and demonstrated competency in the use and operation
of PET/CT or SPECT/CT systems.

(6)(a) Appropriate
additional training is considered training that covers the topic areas outlined
in the PET/CT curriculum developed by the Multi-Organizational Curriculum Project
Group sponsored by the American Society of Radiologic Technologists and the Society
of Nuclear Medicine Technologists, or equivalent training approved by the Authority;
and

(b) Includes
the content specified in the PET/CT curriculum for the area(s) that the individual
is not already trained or certified in; or

(c) Individuals
meeting the requirements of section (4) of this rule and who have successfully completed
training that the Authority has evaluated and judged to be substantially equivalent
to that specified in subsection (6)(a) of this rule.

(7) An R.T.
(N) or CNMT certified in Computed Tomography through the American Registry of Radiologic
Technologists is considered to have met the training requirements in section (4)
of this rule.

(8) Technologists
operating PET/CT or SPECT/CT systems must do so under the direction of an authorized
user licensed to perform imaging and localization studies in accordance with OAR
333-116-0320.

Except as provided
in OAR 333-116-0740, the licensee shall require the authorized medical physicist
to be an individual who:

(1) Is certified
by a specialty board whose certification process has been recognized by the Commission
or an Agreement State and who meets the requirements in subsection (2)(b) and section
(3) of this rule. To have its certification process recognized, a specialty board
shall require all candidates for certification to:

(a) Hold
a master's or doctor's degree in physics, medical physics, other physical science,
engineering, or applied mathematics from an accredited college or university;

(b) Have
two years of full-time practical training and supervised experience in medical physics:

(A) Under
the supervision of a medical physicist who is certified in medical physics by a
specialty board recognized by the Commission or an Agreement State; or

(B) In clinical
radiation facilities providing high-energy, external beam therapy (photons and electrons
with energies greater than or equal to one million electron volts) and brachytherapy
services under the direction of physicians who meet the requirements for authorized
users in OAR 333-116-0740, 333-116-0690 or 333-116-0720; and

(2) Holds
a master's or doctor's degree in physics, medical physics, other physical science,
engineering, or applied mathematics from an accredited college or university; and
has completed one year of full-time training in medical physics and an additional
year of full-time work experience under the supervision of an individual who meets
the requirements for an authorized medical physicist for the type(s) of use for
which the individual is seeking authorization.

(a) This
training and work experience must be conducted in clinical radiation facilities
that provide high-energy, external beam therapy (photons and electrons with energies
greater than or equal to one million electron volts) and brachytherapy services
and must include:

(b) Has obtained
written attestation that the individual has satisfactorily completed the requirements
in subsections (1)(a) and (1)(b) of this rule, or subsection (2)(a) and section
(3) of this rule, and has achieved a level of competency sufficient to function
independently as an authorized medical physicist for each type of therapeutic medical
unit for which the individual is requesting authorized medical physicist status.
The written attestation must be signed by a preceptor authorized medical physicist
who meets the requirements in this rule, OAR 333-116-0740, 333-116-0905, or equivalent
Agreement State requirements for an authorized medical physicist for each type of
therapeutic medical unit for which the individual is requesting authorized medical
physicist status; and

(3) Has training
for the type(s) of use for which authorization is sought that includes hands-on
device operation, safety procedures, clinical use, and the operation of a treatment
planning system. This training requirement may be satisfied by satisfactorily completing
either a training program provided by the vendor or by training supervised by an
authorized medical physicist authorized for the type(s) of use for which the individual
is seeking authorization.

Except as provided in OAR 333-116-0740, the licensee shall require the authorized nuclear pharmacist to be a pharmacist who:

(1) Is certified by a specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in subsection (2)(b) of this rule. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(a) Have graduated from a pharmacy program accredited by the American Council on Pharmaceutical Education (ACPE) or have passed the Foreign Pharmacy Graduate Examination Committee (FPGEC) examination;

(b) Hold a current, active license to practice pharmacy;

(c) Provide evidence of having acquired at least 4000 hours of training/experience in nuclear pharmacy practice. Academic training may be substituted for no more than 2000 hours of the required training and experience; and

(d) Pass an examination in nuclear pharmacy administered by diplomates of the specialty board, that assesses knowledge and competency in procurement, compounding, quality assurance, dispensing, distribution, health and safety, radiation safety, provision of information and consultation, monitoring patient outcomes, research and development; or

(2)(a) Has completed 700 hours in a structured educational program consisting of both:

(A) 200 hours of classroom and laboratory training in the following areas:

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity;

(iv) Chemistry of byproduct material for medical use; and

(v) Radiation biology; and

(B) Supervised practical experience in a nuclear pharmacy involving:

(i) Shipping, receiving, and performing related radiation surveys;

(ii) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides;

(iii) Calculating, assaying, and safely preparing dosages for patients or human research subjects;

(iv) Using administrative controls to avoid medical events in the administration of byproduct material; and

(v) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and

(b) Has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in subsections (1)(a), (1)(b), and (1)(c) or (2)(a) of this rule and has achieved a level of competency sufficient to function independently as an authorized nuclear pharmacist.

A licensee may apply for and must receive a license amendment identifying an experienced nuclear pharmacist before it allows this individual to work as an authorized nuclear pharmacist. A pharmacist who has completed a structured educational program as specified in OAR 333-116-0910(2)(a) before December 2, 1994, and who is working in a nuclear pharmacy would qualify as an experienced nuclear pharmacist. An experienced nuclear pharmacist need not comply with the requirements on preceptor statement in 333-116-0910(2)(b) and recentness of training in 333-116-0760 to qualify as an authorized nuclear pharmacist.

(1) A licensee
must report any medical event, except for an event that results from patient intervention,
in which the administration of radioactive material or radiation from radioactive
material results in:

(a) A
dose that differs from the prescribed dose or dose that would have resulted from
the prescribed dosage by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5
Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to
the skin; and

(A) The
total dose delivered differs from the prescribed dose by 20 percent or more;

(B) The
total dosage delivered differs from the prescribed dosage by 20 percent or more
or falls outside the prescribed dosage range; or

(C) The
fractionated dose delivered differs from the prescribed dose, for a single fraction,
by 50 percent or more.

(b) A
dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to
an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from
any of the following:

(B) An
administration of a radiopharmaceutical drug containing radioactive material by
the wrong route of administration;

(C) An
administration of a dose or dosage to the wrong individual or human research subject;

(D) An
administration of a dose or dosage delivered by the wrong mode of treatment; or

(E) A
leaking sealed source.

(c) A
dose to the skin or an organ or tissue other than the treatment site that exceeds
by 0.5 Sv (50 rem) to an organ or tissue and 50 percent or more of the dose expected
from the administration defined in the written directive (excluding, for permanent
implants, seeds that were implanted in the correct site but migrated outside the
treatment site).

(2) A
licensee must report any event resulting from intervention of a patient or human
research subject in which the administration of radioactive material or radiation
from radioactive material results or will result in unintended permanent functional
damage to an organ or a physiological system, as determined by a physician.

(3) The
licensee must notify by telephone the Authority no later than the next calendar
day after discovery of the medical event.

(4) The
licensee must submit a written report to the Authority within 15 days after discovery
of the medical event.

(a) The
written report must include:

(A) The
licensee's name;

(B) The
name of the prescribing physician;

(C) A
brief description of the event;

(D) Why
the event occurred;

(E) The
effect, if any, on the individual(s) who received the administration;

(F) What
actions, if any, have been taken or are planned to prevent recurrence; and

(G) Certification
that the licensee notified the individual (or the individual's responsible relative
or guardian), and if not, why not.

(b) The
report may not contain the individual's name or any other information that could
lead to identification of the individual.

(5) The
licensee must provide notification of the event to the referring physician and also
notify the individual who is the subject of the medical event no later than 24 hours
after its discovery, unless the referring physician personally informs the licensee
either that he or she will inform the individual or that, based on medical judgment,
telling the individual would be harmful. The licensee is not required to notify
the individual without first consulting the referring physician. If the referring
physician or the affected individual cannot be reached within 24 hours, the licensee
must notify the individual as soon as possible thereafter. The licensee may not
delay any appropriate medical care for the individual, including any necessary remedial
care as a result of the medical event, because of any delay in notification. To
meet the requirements of this rule, the notification of the individual who is the
subject of the medical event may be made instead to that individual's responsible
relative or guardian. If a verbal notification is made, the licensee must inform
the individual, or appropriate responsible relative or guardian that a written description
of the event can be obtained from the licensee upon request. The licensee must provide
such a written description if requested.

(6) Aside
from the notification requirement, nothing in this section affects any rights or
duties of licensees and physicians in relation to each other, to individuals affected
by the medical event, or to that individual's responsible relatives or guardians.

(B) When the treatment consists of three or fewer fractions and the calculated total administered dose exceeds total prescribed dose by more than ten percent of the total prescribed dose;

(C) When the calculated weekly administered dose is 30 percent greater than the weekly prescribed dose; or

(D) When the calculated total administered dose exceeds the total prescribed dose by more than 20 percent of the total prescribed dose.

(f) A brachytherapy radiation dose:

(A) Involving the wrong individual, wrong radioisotope, or wrong treatment site (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site); or

(B) Involving a sealed source that is leaking;

(C) When, for a temporary implant, one or more sealed sources are not removed upon completion of the procedure; or

(D) When the calculated administered dose exceeds the prescribed dose by more than 20 percent of the prescribed dose.

(2) The licensee must notify by telephone the Authority no later than the next calendar day after discovery of the medical event.

(3) The licensee must submit a written report to the Authority within 15 days after discovery of the misadministration.

(a) The written report must include:

(A) The licensee's name;

(B) The name of the prescribing physician;

(C) A brief description of the event;

(D) Why the event occurred;

(E) The effect, if any, on the individual(s) who received the administration;

(F) What actions, if any, have been taken or are planned to prevent recurrence; and

(G) Certification that the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not.

(b) The report may not contain the individual's name or any other information that could lead to identification of the individual.

Report and Notification of a Dose to an Embryo/Fetus or a Nursing Child

(1) A licensee must report any dose to an embryo/fetus that is greater than 50 mSv (5 rem) dose equivalent that is a result of an administration of byproduct material or radiation from byproduct material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user.

(2) A licensee must report any dose to a nursing child that is a result of an administration of radioactive material to a breast-feeding individual who:

(a) Is greater than 50 mSv (5 rem) total effective dose equivalent; or

(b) Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.

(3) The licensee must notify the Authority by telephone no later than the next calendar day after discovery of a dose to the embryo/fetus or nursing child that requires a report in sections (1) or (2) of this rule.

(4) The licensee must submit a written report to the Authority within 15 days after discovery of a dose to the embryo/fetus or nursing child that requires a report in sections (1) or (2) of this rule.

(a) The written report must include:

(A) The licensee's name;

(B) The name of the prescribing physician;

(C) A brief description of the event;

(D) Why the event occurred;

(E) The effect, if any, on the embryo/fetus or the nursing child;

(F) What actions, if any, have been taken or are planned to prevent recurrence; and

(G) Certification that the licensee notified the pregnant individual or mother (or the mother's or child's responsible relative or guardian), and if not, why not.

(b) The report must not contain the individual's or child's name or any other information that could lead to identification of the individual or child.

(5) The licensee must provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than 24 hours after discovery of an event that would require reporting under sections (1) or (2) of this rule, unless the referring physician personally informs the licensee either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful. The licensee is not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within 24 hours, the licensee must make the appropriate notifications as soon as possible thereafter. The licensee may not delay any appropriate medical care for the embryo/fetus or for the nursing child, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this rule, the notification may be made to the mother's or child's responsible relative or guardian instead of the mother. If a verbal notification is made, the licensee must inform the mother, or the mother's or child's responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee must provide such a written description if requested.

A licensee must file a report with the Authority within five days if a leak test required by OAR 333-116-0200 reveals the presence of 185 Bq (0.005 uCi) or more of removable contamination. The written report must include:

(1) The model number and serial number of the leaking source, if assigned;

The official copy of an Oregon Administrative Rule is
contained in the Administrative Order filed at the Archives Division,
800 Summer St. NE, Salem, Oregon 97310. Any discrepancies with the
published version are satisfied in favor of the Administrative Order.
The Oregon Administrative Rules and the Oregon Bulletin are
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